Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Alert on voluntary recall and corrective action by defibtech on semi-automatic external defibrillators the department of health (dh) today (may 4) draws public's attention to a worldwide voluntary recall by a us medical device manufacturer, defibtech, regarding its ddu-100 series semi-automatic external defibrillators (aeds) because in some instances, the shock is cancelled during the charging process. corrective action involves software upgrading. the defibrillators are sold under the brand names of lifeline aed, reviver aed and lifeforce aed.
a spokesman for dh remarked that the department's medical device control office came to learn of the above recall through its surveillance scheme.
the spokesman then explained, "the defect may result in the defibrillators unable to provide therapy which may mean failure to resuscitate patients. moreover, the defect is not detectable by periodic self-test. however, according to information provided by the manufacturer, the odds of the occurrence of the defect are very very rare."
so far, dh has not received any report of adverse incident arising from the defective devices.
"therefore, defibtech recommends that customers can keep their devices in service until the company has performed the software upgrade. the latter can be performed at the location where the devices are deployed," the spokesman said.
"dh understands that international regulatory authorities including uk's medicines and healthcare products regulatory agency and us' food and drug administration also find the proposed course of action acceptable."
in hong kong, defibtech's record indicated that 82 affected devices have been distributed here. customers can check the nine-digit serial number on the back of the aeds against the list published by defibtech at www.Defibtech.Com/fa11 to see if their devices are affected.
"after risk assessment, dh also concurs that those who possess the affected products can keep their devices and contact their distributor or the us manufacturer for software upgrade. further information on this issue can be obtained from defibtech's website at www.Defibtech.Com/news/20110429.Html," the spokesman stated.
dh will be monitoring the progress of the corrective action closely.
ends/wednesday, may 4, 2011.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of braunoderm disinfectant solution
the department of health (dh) today (may 23) endorsed the voluntary recall of three batches of "braunoderm" iodine solution by its german manufacturer b. braun medical ag as less than the specified amount of the active ingredient, iodine was detected in the products through ongoing in-house monitoring.
dh is notified of the move by the product's local supplier, united base (hong kong) ltd. the latter reports that regular stability analysis by the product manufacturer reveals that the level of available iodine in some batches falls slightly under the shelf-life specification before the expiry date is reached.
the exact details of the three batches under global recall are -
a) braunoderm ungef variofl 'de' 1000ml (article no.: 3881156, batch no.: 0253m14)
b) braunoderm ungef spruehfl 'de' 250ml (article no.: 3881105, batch no.: 0253m14)
c) braunoderm ungef spruehfl 'de' 1000ml (article no.: 3881105, batch no.: 0103m11)
in hong kong, only (b) has been imported by united base for distribution to public and private hospitals, dialysis centres and nursing home.
"although b braun assesses that the effectiveness of the disinfectant is unlikely to be compromised as the insufficiency is only marginal, to be prudent, dh endorses the recall, especially as we understand that in hong kong, the product is also used by hospitals and dialysis centres to disinfect haemodialysis equipment besides for skin disinfection," a dh spokesman remarks.
"given that renal patients are chronically ill and often also immune-compromised, their safety cannot be overlooked," the spokesman supplements.
it is reassuring that so far, dh has not received any report of adverse event related to the affected product. all healthcare institutions which have received the affected product have been approached by united base for the recall.
united base (hong kong) ltd. has also set up hotlines 2959 6138 or 9859 0231 to answer related enquiries.
the spokesman urges individual customers and healthcare providers who still have the affected disinfectant in hand to stop using it immediately and to choose substitutes from alternatives available on the market.
he reaffirms that dh will continue its investigation, closely monitor the recall and seek legal advice for suspicion of any breach of the law.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety alert over certain cameron pulse generators the department of health (dh) has drawn public attention to a field safety advisory relayed by the uk medicines and healthcare products regulatory agency concerning possible premature battery depletion in a number of sq-rx pulse generators by cameron health. the pulse generators are a component of the cameron health s-icd system, which is an implantable cardioverter-defibrillator prescribed for patients when cardiac arrhythmia management is warranted.
according to the advisory, spotted via dh's regular surveillance, medical device manufacturer cameron health, inc. determined that a specific subset of sq-rx pulse generators, model number 1010 may not achieve the five-year typical longevity due to premature battery depletion.
premature battery depletion under this condition may also result in the time between the onset of the elective replacement indicators (eri) and end of life (eol) indicators to be less than the nominal three months. therapy remains available through the onset of eri, but may not be available throughout the period between eri and eol.
cameron health has confirmed one occurrence of a device experiencing premature battery depletion as described above but no patient injury or deaths related to this condition have been reported.
while dh is following up with the manufacturer on the supply of the device in hong kong, a spokesman urges patients who might have the affected device implanted to contact their physicians immediately should they notice an audible tone emitted from the device or should they have any queries.
the department has alerted the hospital authority, private hospitals, relevant institutions and medical associations to the field safety notice.
while dh has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Safety alert over roche blood glucose strip the department of health (dh) today (june 21) draws public's attention to the recall of a medical device in france, accu-chek performa strip, a blood glucose test strip of roche diagnostics, as the strip may give falsely high blood sugar reading, thereby has the potential to cause fatal mis-management of diabetic patients.
the alert comes to dh's notice through its surveillance system on medical device mishaps. accu-chek performa strip is meant for used together with its home-use performa system by diabetic patients for self- monitoring of their blood glucose status.
according to information available to the us food and drug administration, a specific lot
(batch no.:470049) of the test strip referred to has the above deficiency.
a spokesman for dh explains that falsely high blood glucose reading may cause a diabetic patient to mis-handle his condition, resulting in the life-threatening condition of hypoglycaemia.
preliminary enquiry on the local supplier, roche diagnostics (hong kong) limited revealed that the affected lot of performa blood glucose strip is for sale in france only and has not been imported into hong kong.
“though the affected lot has not been introduced into the hong kong market, the possibility of possession by individual diabetic patients cannot be ruled out, mindful of the option of internet trading and also the abundance of international travellers in hong kong. because of the dreaded consequences here, dh opts that a public alert is still warranted,”the spokesman stresses.
"any one who has the failed lot of device in his possession must stop using it and
contact roche diagnostic (hong kong) for follow-up," the spokesman urges. it is understood that the company has set up a hotline 2485 7512 to handle the matter.
so far, the dh has not received any report of adverse events arising from use of the affected product. however, the spokesman does remind that for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their healthcare professionals for advice as soon as possible.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Alert on performance of two automated external defibrillators the department of health (dh) draws public's attention to performance defects in two brands of automated external defibrillators (aeds), meducore easy and lifepak 500, made respectively by two medical device manufacturers, weinmann and medtronic, because of potential malfunctions in both.
the two incidents come to dh's notice through its surveillance system on medical device mishaps. both devices are designed for use during cardiopulmonary resuscitation.
according to weinmann, the time allotted for charging the capacitor in meducore easy is insufficient for a full charge and hence may result in device failure. the incomplete charging can be eliminated through a modification to the firmware and weinmann urges customers to send their devices to their local suppliers for upgrading.
the second incident involves lifepak 500 aed, created by physio control, a division of medtronic. it is noted that the electronic component on the main printed circuit board of a certain number of devices is susceptible to moisture, which could again cause malfunction as a result.
physio control remarks that two patients were reported as unable to be resuscitated. however, definitive causal conclusions still remain to be determined. nevertheless, the company is advising customers to contact their local service personnel for their follow-up.
dh's preliminary inquiries on the two manufacturers, including their local suppliers, reveal that while no meducore easy device has been supplied to hong kong, two lifepak 500 aeds are available locally. both are only for use in demonstrations and thus not meant for sale.
"despite the above, the possibility of possession of the above devices by individual customers cannot be ruled out and given the dreaded potential consequence of failed resuscitation, dh opts that a public announcement is warranted as a matter of prudence," a spokesman for dh explains.
so far, dh has not received any report of adverse incident related to the two brands of aeds in hong kong.
"anyone who has the aeds in question should take note of the announcement and act according to the corrective actions suggested by the manufacturers as soon as possible," the spokesman reminds the public.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: varian eclipse treatment planning system: eclipse release 6.5 through 10 (versions 7.3.10 to 10.0.34), model: h48
it has come to our attention that varian medical systems, inc. has issued a global field safety notice to customers regarding the captioned planning system used in radiotherapy treatments. according to the manufacturer, hong kong is affected.
in affected eclipse versions, user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. varian is preparing a maintenance release (service pack) of eclipse software to address the problem.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: smith & nephew, tendon stripper, slotted, 5.0 mm i.D. x 12” working length
it has come to our attention that smith & nephew endoscopy has issued a product recall regarding eleven lots of tendon stripper. according to the local supplier, hong kong is affected.
the material of shaft tip (casting) does not meet with the manufacturer’s specification, which could result in rusting of the tendon strippers. this condition could make the device difficult to clean and therefore challenging to adequately sterilize.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Alert on product recall: banitore basic dressing pack
local supplier hengan pharmacare co., ltd. is conducting a voluntary recall of one batch (lot no.: 20100520) of “banitore basic dressing pack”.
the recall is made after the firm’s investigation of a product complaint on 30 june 2011 because residual cotton fabric was found in a certain swab. according to the local supplier, the affected swab has been undergone complete sterilization process and it was safe to use. however, as a precaution, the local supplier is conducting a voluntary recall of this batch of dressing pack.
if you are in possession of the affected product, please contact the supplier (hotline: 2604 2317) for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: thermo fisher scientific, thermo scientific microm hm355s
thermo fisher scientific has issued a safety advisory notice regarding the captioned device. according to the local supplier, the device is available in hong kong.
the manufacturer will modify the user manual as follows:
a modification to the chapter regarding safe work practices for the instrument as well as additional instructions on proper brake usage has been made more specific.
a new quick-reference card is being provided which summarizes the enhancements made to the user manual.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: boston scientific promus elementtm everolimus-eluting coronary stent system
boston scientific has issued a product recall regarding three units of promus elementtm everolimus-eluting coronary stent system. according to the local supplier, hong kong is not affected.
the three units were shipped from the australia distribution center between may 30, 2011 and may 31, 2011 without the appropriate australia directions for use (dfu) inserted.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Advisory notice: abbott medical optics (amo) star s4 ir excimer laser system software, versions 5.00 through 5.22 and versions 5.00 through 5.30
abbott medical optics (amo) has issued an advisory notice to customers of amo star s4 ir excimer laser system and customers of amo wavescan wavefront system regarding a defect of the iris registration (ir) software on the star s4 ir excimer laser system, versions 5.00 through 5.22 and versions 5.00 through 5.30 respectively. there is a malfunction of the compensation for pupil centroid shift in the affected software versions, which may lead to visual disturbances or reduced best corrected visual acuity.
according to the local supplier, the affected products are available in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: boston scientific resolution® ii clip
boston scientific has issued a field safety notice to customers of resolutionr ii clip. according to the local supplier, hong kong is not affected.
the manufacturer states that following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip. this has resulted in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: tomotherapy treatment systems hi‧art versions 4.0.X, and hd versions 1.0.X
tomotherapy has issued a field safety notice to customers of tomotherapy treatment systems with hi·art versions 4.0.X, and hd versions 1.0.X. there is an anomaly in the software, in which during dicom export of plan level images with a non square exported field of view, an anomaly in the process of squaring the plan level image may cause the image to shift with respect to rois and dose.
according to the local supplier, the affected products are available in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: 4d integrated treatment console v8.6 with aria rt chart v8.5, all of 4ditc v8.3
medical device manufacturer, varian, has issued an urgent field safety notice to the customers of 4ditc v8.6 with aria rt chart v8.5, all of 4ditc v8.3.
the 4ditc may erratically fail to load the planned wedge without warning or notification when receiving an approved plan from the oncology information system (ois). delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. this errant behavior may occur with the above-affected releases of 4d integrated treatment console, v8.6 or earlier.
to avoid the issue, the manufacturer recommended customers to make workflow adjustments in their planning, scheduling, and delivery portions prior to delivering a wedge field treatment.
according to the local supplier, hong kong is affected.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Alert on product recall: coseal surgical sealant
baxter healthcare ltd is voluntarily recalling one lot of coseal surgical sealant (product code: 934074, lot no. ha090947, with expiry date 08/31/11) as a precautionary measure. one parameter of the device in the manufacturer’s stability test is found to be out of specification and there is possible failure for the product to gel appropriately. the manufacturer claimed that such failure does not represent risk for patient’s life.
the manufacturer further asked the users to stop using the above lots and to quarantine any units that may be put in the users’ inventory. if the product cannot gel appropriately, users may use of a second kit of product or alternative method for hemostasis. the measures have been described in the ifu of the device.
according to the local supplier, the affected products have been distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of alterna® sterile post-operative ostomy bags due to sterility problem after assessing a notification from a local medical device supplier, coloplast (hong kong) ltd, about its proposal to recall one of its product alterna® sterile post-operative ostomy bag from consumers on sterility ground, the department of health (dh) endorsed the action.
coloplast, the manufacturer of the device under recall, found during routine product sterility test that a lot has failed. investigation reveals that the failed lot of product was sterilised after january 2010, when the sterilisation process was moved over to a new site. thus, coloplast decided to conduct a recall of all products sterilised at the new site, though no report of any adverse incident arising from the use of ostomy bags produced in the new site has been received worldwide. dh also had not received any such notification locally.
the models under recall are 12808, 12810 and 12818, all with expiry date on january 1, 2013 or later.
alterna® sterile post-operative ostomy bag is used for collecting output from stoma - an opening created on the abdomen after bowel or urinary tract surgery in order to divert faeces or urine respectively.
a spokesman for dh said, "since there is concern over the sterility of the product, with potential risk of infection, the department endorses coloplast (hong kong) ltd's recall as a measure to safeguard public health."
coloplast (hong kong) ltd's sales record showed that its products have been sold to both hospitals and patients here in hong kong.
"customers who have the affected products in hand should return them to coloplast (hong kong) ltd. the company can be reached through its hotline at telephone number 3628 7436. people who have used the products should also consult their healthcare professionals if feel unwell or in doubt," the spokesman advised.
dh had already alerted the hospital authority, private hospitals, relevant healthcare institutions and medical associations about the matter, and will closely monitor the recall besides continuing investigation.
ends/thursday, july 28, 2011
issued at hkt 20:58.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of two mona lisa intrauterine contraceptive devices (with photo) the department of health (dh) today (july 29) instructed a local medical devices supplier, cnw far east limited (cnwfe), to recall all batches of two of its intrauterine contraceptive devices (iucds), mona lisa cut 380a and mona lisa nt cu 380, from shelves following discovery of mislabelling and wrong packaging involving the two models.
the discovery was by the dh's chai wan maternal and child health centre (mchc) when they served a family planning client yesterday. on opening a cut 380a package, staff discovered that an nt cu 380 device was found instead.
"cut 380a has a life span of 10 years while nt cu 380 has only half that - five years," a dh spokesman stated. "as the client had expressed no preference on her choice, the nt cu 380 was inserted and she was also told so."
being unusual, the incident was reported by the mchc to the medical device control office in the dh. the latter began investigation immediately and findings so far reveal that the entire production chain for mona lisa iucds actually takes place in belgium.
the spokesman said that although the two devices differ only in terms of life span and the dh is not aware of related notifications here or worldwide, to be prudent, the client was contacted. she opted for an alternative mode of contraception on learning of the matter.
"moreover, we have referred the case to our belgian counterpart for their follow-up action. meanwhile, cnwfe is also instructed to recall both products from shelves, pending investigation findings in belgium. however, at present, there is no evidence to indicate that clients with the devices inserted require removal," the spokesman said.
given that sales records show that the devices have been distributed to health-care institutions and private doctors, the dh has brought the matter to relevant stakeholders' attention.
"health-care professionals and retailers should stop supplying the said products to clients immediately. cnwfe has set up a hotline, 2388 2933, to answer related enquiries," the spokesman said.
"and to cater for enquiries from mchc's clients, the dh will also operate a hotline, 2125 1133, from tomorrow onward," the spokesman added.
the spokesman emphasised that the dh will be monitoring the recall besides continuing the investigation with belgian collaboration.
ends/friday, july 29, 2011
issued at hkt 21:37.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Fda class i recall: gem premier 4000 pak cartridges for use on the gem premier 4000 system
it has come to our attention that the u.S. food and drug administration (fda) has issued an class i recall to remind healthcare providers and patients that gem premier 4000 pak cartridges for use on the gem premier 4000 portable critical care system, which is manufactured by instrumentation laboratory company, may give inaccurate results.
potassium test results on the gem premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/l by as much as 2.0 mmol/l. use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death.
to avoid this, the manufacturer recommended customers to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting.
according to the local supplier, hong kong is affected. the local supplier has contacted the affected customers for corrective actions
for details, please refer to the following link:
http://www.Fda.Gov/safety/medwatch/safetyinformation/
safetyalertsforhumanmedicalproducts/ucm266113.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: philips allura xper systems - allura xper fd10 (f/c), allura xper fd10/10 (incl. or table), allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20
philips healthcare has issued a field safety notice to the customers of allura xper systems.
investigation of field problems on the allura xper systems showed that there is a problem related to the harddisk firmware. the hard disk drive itself is working fine but the used firmware suffers from an incorrect incrementing smart counter. this might result in a very high “raw read error” count which will lead in a so called “smart trip” and subsequently will take the hard disk drive offline. consequently the system might intermittently freeze. this can vary from several seconds up to one minute.
if during a procedure the system intermittently freezes for several seconds and up to one minute, the system does not generate x-ray anymore and no geometry movement is possible during this period of time. if this happens during a critical phase in a procedure this might lead to a disturbance in the procedure and a possible injury to the patient.
this intermittent image freeze / system freeze is not foreseeable or recognizable by the user. the manufacturer recommended customers not to reboot or take any other actions until the system proceeds on its own, because this could slowdown the systems automatically recovery. the manufacturer will provide users a cd with the correct firmware and an installation procedure to implement the corrective actions.
according to the local supplier, hong kong is affected. the local supplier is following up the issue with its customers.
if you are in possession of the affected product, please contact your supplier (hotline: 2821-5473) for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Fda class i recall: ge healthcare vital signs hygroscopic condenser humidifier passive humidification device (hch) for vital signs anesthesia breathing circuits
it has come to our attention that the u.S. food and drug administration (fda) has issued a class i recall concerning ge healthcare vital signs hygroscopic condenser humidifier passive humidification device (hch) for vital signs anesthesia breathing circuits.
the vital signs hch is sold as part of the vital signs anesthesia breathing circuit. an hch is used to maintain moisture in the patient's airway during mechanical ventilation. the affected device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.
clinical users have been directed to not use the anesthesia circuits containing the vital signs devices passive humidification device (hygroscopic condenser humidifier, or "hch"), or the stand alone hch device with the affected product item numbers and lot numbers, and to isolate all affected product.
according to the local supplier, hong kong is not affected.
for details, please visit the following fda website:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm266542.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: use of brainlab skull reference base in combination with kls martin cross-drive screws
brainlab ag has issued a product notification regarding the use of the brainlab disposable self-tapping screw 1.5 x 6mm (art. no. 52128) / kls martin cross-drive screw 1.5x6mm (art. no. 25-678-06) in combination with the brainlab skull reference base (art. no. 52121b, 52129, 52129a).
applying too much torque or tensile force to the head of the screw during insertion and fixation of the skull reference base may cause the screw head to deform or to shear off. in such case, the screw can no longer be removed using the specified screwdriver or parts of the screw may remain inside the patient’s skull bone.
depending on the used skull reference base version, brainlab ag will provide customers with updated instructions for use regarding safe use of the skull reference array kit.
according to the local supplier, hong kong is affected.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Fda class i recall: arrow nextstep antegrade chronic hemodialysis catheter manufactured between april 14, 2011 and may 9, 2011
it has come to our attention that the u.S. food and drug administration (fda) has issued a class i recall to healthcare professionals followed by complaints received by the manufacturer indicating breakage and/or separation of the stylet within the arrow nextstep antegrade catheters.
the arrow nextstep antegrade catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis.
affected models include:
model no.
lot no.
cs-15192-ixm
rv1034909
cs-15232-ixm
rv1034911
cs-15272-ixm
rv1034912
cs-15312-ixm
rv1034913
cs-15422-ix
rv1034914
cs-15502-ix
rv1034915
according to the supplier, the affected product was not distributed in hong kong. if you happen to have the affected product in hand, you are advised to contact your supplier for necessary actions.
for details, please visit the following fda website:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm266463.Htm.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Field safety notice: boston scientific katzen™ infusion wire
boston scientific has issued an urgent product recall of one lot/batch of katzen™ infusion wires (material no. (upn). m001461930; catalogue no. 46-193; lot/batch no. 14270326; expiry date march 2014) because the label on the carton and the inner pouch indicates an incorrect device length.
according to the manufacturer, no injuries are expected to occur as a result of this mislabeling. if physician could not reach the target anatomic location because the device was shorter than expected, a minimal delay in the procedure would occur. boston scientific suggests immediately ceasing further distribution or using of any remaining products affected by this recall. recalled products will be replaced.
according to the local supplier, hong kong is not affected.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device recall: boston scientific expect™ endoscopic ultrasound aspiration needle
boston scientific issued an urgent product recall of one batch of incorrect labelled expecttm endoscopic ultrasound aspiration needle (product description; eus fna single pack 25ga; material/upn/catalog number m00550020; batch no.13615651c1; expiry date 30 june 2014). the pouch label upn number and device handle correctly indicate that it was a 25 ga device, while the graphics on the carton label indicated it was a 22 ga device.
according to the manufacturer, no injuries are reasonably expected to occur as a result of this mislabeling issue. boston scientific suggests that users should immediately discontinue use of the product and return to boston scientific.
according to the local supplier, hong kong is not affected by this recall.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Press release
Cause
Recall of bayer's contour and contour ts glucose test strips the department of health (dh) today (august 16) directs a local medical device supplier, bayer healthcare limited (bayer), to recall from consumers all batches of its two products, namely contour and contour ts glucose test strips, as ongoing in-house quality assurance scheme by the manufacturer has detected the production of erroneously low blood glucose readings.
since the consequential hyperglycaemia in users may pose dreaded and even fatal health risks, the recall is therefore a necessity for safeguarding public health .
bayer reports to dh that the issue came to light when the manufacturer, bayer healthcare diabetes, found on routine testing that strips from half of the bottles of 5s, 10s and 25s produced falsely low blood glucose readings. in-house investigation findings so far point to interaction of the strips with the gas trapped inside the bottles as the cause of the defect.
"given that so far there is no indication that the strip and the packing method for each of the four package sizes is unique and not identical, and the lack of a satisfactory explanation for the sparing of the 50-unit bottles, dh considers it only prudent to advise for a blanket recall of all four package sizes, the 50-unit one included. the recall scope will be reviewed on availability of new evidence," a dh spokesman explains.
"that dh is also advising the recall of contour although bayer only sold contour ts in hong kong is because as the manufacturer has already found out that the former is affected as well and given the high prevalence of diabetes mellitus worldwide, international travellers included, plus the popularity of internet sales, we consider the inclusion of contour test strip as an integral element of a global control effort," the spokesman elaborates.
indeed, bayer's sales record shows that contour ts has been sold to public and private hospitals, private practitioners and also retailers. in connection, dh has informed the hospital authority, all private hospitals and nursing homes. it is understood that bayer has set up phone hotlines at 2814 5121 and 2814 4846 for handling enquiries.
"so far, there is no evidence to suggest that bayer's other glucose test strips, including that for use with the breeze 2 meter on sale locally, are affected. moreover, no related adverse incident report has been received either here or worldwide. however, dh will continue to investigate, including working with overseas counterparts, for both the cause and the scope," the spokesman emphasizes.
"consumers are advised to switch to unaffected options in the market for blood glucose monitoring. however, pending the availability of an alternative in hand, consumers must not discontinue monitoring with any of the affected strips as the risk of not monitoring their blood glucose may outweigh erroneously low blood glucose readings obtained under the present circumstances. in any case, they ought to consult their healthcare providers for switching advice, or whenever in doubt or feel unwell," the spokesman urges.