Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
It has been identified that there can be a 2mm +/- overall length difference between various manufacturers pp3 batteries that could be used in niki t34 ambulatory syringe pumps. this could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.
Action
If a battery within the NIKI T34 housing appears loose, careful adjustment of the battery connections may be required as detailed in the Customer letter
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Medtronic has identified that the irrigation pin used to manufacture (moulding) the hub outer tube was incorrectly placed in the mould. the use of a shorter pin resulted in blockage of the irrigation lumen of specific straightshot microdebrider blades.To date, there have been no reported injuries as a result of this issue.
Action
Medtronic is advising customers to cease use of affected product. Customers are requested to return unused units by following the instructions outlined in the Customer Letter.
Medtronic is advising clinicians who may have used impacted units to monitor their patient's condition to determine if there are any signs of infection. If infection is present, the patient should seek medical attention immediately for treatment.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Two issues have been identified with the samsung digital x-ray system gc80:1. if the user does not completely close the detector tray in the table or stand, the system turns into the portable mode or the multi-portable mode and auto exposure control (aec) turns off. at this time, the screen of workstation and the screen of tube head unit (thu) show the portable mode on or the multi portable mode on and aec off. if the user makes an exposure without checking, it may be irradiated differently than intended and produce an unintended image.2. if the user incorrectly attempts to use a portable detector within the table detector or stand detector areas with the auto detector option switched on, the system may automatically select the table or stand detectors if the focal spot is met. in this situation, if the user attempts an exposure of the portable detector without checking which detector is selected, it may be irradiated differently than intended and produce an unintended image.
Action
Samsung is advising users:
1. Carefully close the detector tray and check that the detector tray is completely closed.
2. When using a portable detector:
a. ensure the portable detector is placed outside the table detector or stand detector area when the auto detector option is switched on; or
b. switch off the auto detector option before exposing patients with a portable detector placed within the table or stand detector areas.
3. Always carefully check the screen of Workstation or the screen of THU before making an exposure, and be sure to check the Receptor (4), AEC mode (7,8), and the exposure condition (1,2,3,5,6,9,10,11,12).
If the intended detector is not set, please select the detector to be used.
Samsung is planning to release updated software (expected to be available 30 June 2018) to prevent the outlined issues occurring. Implementation of the software update will be carried out by Quantum Healthcare Pty Ltd.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Baxter healthcare has identified an issue with the use of an incorrect plastic formulation in the manufacture of the blue luer component of the floseal malleable tips. the plastic formulation does not present any toxicity or biocompatibility concerns, but does impact the physical characteristics of the blue luer component. the affected lots of the floseal malleable applicator tip have been associated with the cracking of the luer upon connection with the syringe. since the tip is attached to the syringe outside of the surgical field, it is unlikely that plastic fragments would reach the surgical field. nevertheless, in exceptional cases, detached subvisible particles may be retained in the body and may cause inflammation, or serve as a nidus for bacteria in already contaminated wounds and contribute to allergic reactions. to date, there have been no reports of serious injury associated with this issue.
Action
Baxter is advising customers to locate and return all units of the affected product. Instructions for return can be found on the Customer Letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Further to the safety alert communication of april 24th 2018 (rc-2018-rn-00337-1), abbott is now advising of the firmware update availability.As part of a planned series of system updates that began in 2017 with the release of merlin@home v8.2.2 software, a firmware update has been developed with the intention to further strengthen the security and improve the performance of high voltage implantable cardiac devices (icds and crt-ds). the firmware upgrade is recommended for all eligible patients and includes the following updates:1. a battery performance alert update to provide further detection capability for premature battery depletion in certain high voltage devices (i.E. battery advisory devices), and2. a cybersecurity update to provide an additional layer of protection against unauthorised device access.
Action
The software upgrade indicated in the previous communication RC-2018-RN-00337-1 will be available in the first week of June 2018.
Abbott is contacting doctors (physicians) to provide details regarding risk and patient management recommendations. Surgeons should consider the information in the letter and their patient's circumstances in deciding whether to update the firmware in implanted devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Further to the april 2018 safety alert communication (rc-2018-rn-00302-1) sent to surgeons in regards to heartmate 3 (hm3) outflow graft twist occlusions, abbott have identified the need for further clarification on the origin of the outflow graft twist, the persistent low flow alarm, additional recommendations for patient management and future mitigations to be implemented. abbott is aware that accumulation of an outflow graft twist may occur at any point post-implantation, which can reduce or stop pump flow. occlusion of the hm3 outflow graft often requires urgent surgical intervention.
Action
Abbott is advising they are investigating mitigations to prevent Outflow Graft twist occlusion. In the interim, Abbott recommends the following for HM3 patients:
Existing Patients:
- Surgeons should refer to the information provided in the Customer Letter for managing patients who have been implanted with HM3
New Patients:
- During implant, when attaching the Outflow Graft to the Pump Cover, a clicking sound will be heard as the Screw Ring is tightened. Continue turning the Screw Ring clockwise until it comes to a complete stop and stops clicking. Firmly hand-tightening the Screw Ring may reduce the risk of Outflow Graft twisting by increasing the resistance to metallic Outflow Graft connector rotation. To avoid damaging the Outflow Graft assembly, do not use tools to tighten the screw ring.
- The proposed clarification on Warning and additional Caution statement will be incorporated into the Instructions for Use
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Siemens is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm {1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
Action
As an immediate measure, Siemens' service organisation limits the maximum manual LAO/ RAO rotation from 25°/sec to 20°/sec and Cran/Caud rotation from 20°/sec to 10°/sec. All other system parameters as well as 3D acquisition and Perivis ion/Peristepping remain unaffected.
Siemens are working on a solution to restore the system back to the original settings, and their service organisation will contact affected users to arrange an appointment to carry out the corrective action.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
During a dbs lead implant procedure, the fhc depth stop adapter is placed onto the lead to set the desired distance to target. the depth stop adapter then mounts in the lead measurement fixture to ensure that the lead is not inserted beyond the targeted depth. the fhc depth stop adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. this damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure. recent reports of lead short circuit events have led to an improvement of the depth stop design and a recall the previous version of this product. to date, there have been no reports of patient death related to this problem.
Action
Emergo is advising FHC and Medtronic Field Representatives will review user's inventory and replace affected Depth Stop Adapters on hand with an improved design.
In the interim, Emergo advise that users do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Emergo Australia, or their local field rep.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Siemens is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm (1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
Action
Thermo Fisher are advising users to inspect stock and quarantine all unused units from lot 20180120. Thermo Fisher will arrange recovery and replacement of impacted stock.
Correctly labelled product will be available in the next 3-4 weeks.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Qiagen have identified that the kit lots160017650, 160017770, and 160020069 contain a non-conforming ez1 dsp virus reagent cartridge lot (reg cart virus lot160011000). in the affected reagent cartridges, the proteinase k solution in well 10 is missing, i.E. well 10 is empty. at a maximum, eight of the 48 reagent cartridges in one kit are affected. all affected reagent cartridges are on position 6 within the clamshell box.
Action
Qiagen is advising users to immediately discontinue use and dispose of kits with lots 160017650, 160017770, 160020069, and/or REAG CART LOT 160011000. Users should contact Qiagen technical service to arrange replacement.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Getinge has identified that a screw is missing from the racket of the cupola on some devices in production. it is not yet confirmed whether the screw was missed during manufacture or had loosened over the life of the device. as a consequence the light head shaft could break and the cupola could detach itself when manipulated and be held only by its cables. it appears such event is more likely to happen mainly during maintenance, cleaning and surgery preparation.
Action
Getinge are advising they will contact affected sites to plan for update of devices.
In the interim, users should verify whether the cupola has mechanical play by following the guidance provided in the Customer Letter. If no play in the cupola is detected the device may continue to be used. If play is detected, users should cease use of the device and contact Getinge immediately.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Medtronic has identified the potential for the device to have a misassembled (reversed) sled component. the sled component is responsible for staple deployment. when the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. this may result in bleeding, immediate anastomotic leak, and/or the potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery. internationally, medtronic have received one report of injury related to this issue. to date, there have been no reported injuries in australia.
Action
Medtronic is advising customers to immediately discontinue use of the affected products. Unused product should be quarantined and returned to Medtronic by following the instructions outlined on the Customer Letter. Medtronic will arrange collection of stock from customers and issue a credit for returned goods.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Siemens healthineers are aware of potentially incorrect tube-current calculations by the care dose4d algorithm when utilising only pa or ap topograms. depending on the geometrical shape of the skull, rare cases may occur in which the calculated dose distribution is not appropriate for scans that include the head, when based only on pa or ap topograms. the care dose4d software may select the maximum tube current for the uppermost part of the skull, which incidentally leads to unnecessary radiation exposure.
Action
Siemens is advising that the manufacturer is developing appropriate solutions to address the problem with high priority.
The described issue does not occur when using a lateral topogram. Accordingly, Siemens strongly recommend the utilization of topograms in the lateral position for all CT and PET/CT scans that include the entire head.
Alternatively, if users choose to perform both a lateral topogram, in conjunction with a PA or AP topogram they must ensure that they perform the lateral topogram last as CARE Dose4D is based on the last topogram. If users do not utilize a lateral topogram for scans including the entire head, Siemens strongly recommend that users deactivate the CARE Dose4D feature.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Getinge have received reports where the screws holding the reclining surface on the frame have loosened or completely fallen out. the screws that hold the reclining surface on the frame are not secured against unintentional loosening and the tables may experience this issue with daily use over a number of years. if all screws loosen / become detached and this goes unnoticed, the reclining surface of the table may detach resulting in injury to a patient or operator as a result of falling. to date, no reports of patient injury have been received relating to this issue.
Action
Getinge are advising they will be in contact with impacted users to replace the screws on the table with new screws secured with detent edge discs.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Internationally, three complaints were reported involving mechanical part failures for the leica m320 microscope system. these specific systems had failures with the screws that hold the gas spring fixation bracket in place . due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. this may potentially cause the m320 optics carrier to drop to the lower mechanical end stop.This failure was identical in all three complaints and has been linked to an identified batch of screws, used in the manufacture of the gas spring fixation bracket. these screws have been determined to be non-conforming. in the event that this observed defect were to occur, the m320 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
Action
Leica is advising they will contact affected users to arrange replacement of the mechanical parts of the parallelogram for all M320 microscopes manufactured with screws from the nonconforming batch.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Updated instructions for use (ifu) and cleaning guidelines for the paratherm heater cooler unit have been released.There was a safety alert communicated in april 2017 which referenced the interim cleaning and disinfecting guidelines. during the last 12 months, validation efforts have been undertaken by the manufacturer chalice medical to support the use of a hydrogen peroxide based disinfection agent. this disinfection agent has been subject to review and subsequent inclusion in the australian register of therapeutic goods (amity hp 75, artg 302115, supplied by lovell surgical supplies international as the local sponsor).
Action
Amity HP 75 is to be made commercially available in Australia in June 2018. Stock is currently being manufactured and shipped to Australia. Once available in Australia, Australian Blood Management Unit Trust will be able to facilitate supply of this disinfection agent through Lovell Surgical Supplies International.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Siemens healthcare diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to the hplc method.Cdt results in absolute concentrations may be influenced by patient’s transferrin levels and, therefore, results are reported as ratio of cdt to total transferrin, called %cdt. as the transferrin determination with n antiserum to human transferrin is not affected, the observed effect leads to calculated %cdt values that show a negative bias of approximately 15% compared to the hplc method. this could result in a shift of weak positive patient samples into the reference range of 1.19 – 2.47 %cdt which was derived from a study population of healthy adults.
Action
Siemens Healthcare Diagnostics has assigned optimised values to the affected lots of standards and controls included in the kit lots. Those lots of standards and controls can be used with the revised assigned values and acceptance ranges.
Siemens is advising users to:
· Recalibrate their CDT method with N CDT Standard lots listed in the Customer Letter, using the revised assigned values provided in the communication.
· Use the revised assigned values and respective ranges of the N CDT Controls provided in the Customer Letter.
· For BN ProSpec and Atellica NEPH 630 customers, a new Lot Data CD as well as new Secure Download Files are expected to be available in June 2018 including the revised CDT target values for N CDT Standard, N CDT Control 1 and N CDT Control 2.
· Ensure that the values manually entered according to the Customer Letter are not overwritten by using an older Lota Data CD/Secure Download File afterwards.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Philips have identified an intermittent communication issue between the host system and the flex cardio (fc). it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:- boom monitor may not display all active waveform and/or vital sign data- delayed audible and visual alarms at the fc and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the fc/boom monitor- after patient admission and case initiation at the host system, the case may not be fully transmitted to the fc. in this case, the boom monitor in the exam/procedure room will display vital sign data, but the fc will not provide audible alarms- after patient discharge and case termination at the host system, case termination may not be transmitted to the fc. in this case, the boom monitor in the exam/procedure room will continue to display vital sign data, and the fc will continue to provide audible alarms.
Action
Philips are advising the following to reduce the probability of intermittent communication issues:
- The Flex Cardio must communicate with its host system via an isolated, dedicated Ethernet port
- Do not turn the Flex Cardio device on and/or off while a patient case is open
- Verify that the patient name is visible on the Boom Monitor, which is an indication that the patient case has fully transferred and audible alarms are active. Also, if all expected vital signs are not displayed on the Boom Monitor, close and then re-open the case to resynchronize the Flex Cardio and the host system.
An addendum to the device’s Instructions for Use will be provided to all affected customers by a Philips representative. Philips will also review the contents of the Instructions for Use addendum with each customer and confirm understanding of the addendum’s contents. Affected customers will also be provided with an updated Software and Documentation Media Kit, which contains the IFU addendum.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Whilst conducting production quality checks, dräger became aware of a device where it was possible to dose 100% nitrous oxide. draeger anaesthesia machines are equipped with a mechanical oxygen minimum dosage module (s-orc). this safety feature prevents the user from inadvertently setting hypoxic gas mixtures (with less than 21% oxygen) at the fresh gas mixer when nitrous oxide is selected as one of the carrier gases.In the event of a fault, the s-orc module would not prevent setting a nitrous oxide flow that would result in a hypoxic mixture from being dosed to the patient. the device would deliver exactly the set gas composition, which can be read on the electronic fresh gas flow displays. a hypoxic gas mixture would be immediately visible on the basis of the oxygen monitoring. in addition, visual & audible alarms would be generated if the inspiratory oxygen concentration (fio2) low alarm limit is violated.To date, draeger have not received complaints relating to this issue.
Action
Investigations have determined that the root cause was a burr not being removed from an internal component of the S-ORC during the production process.
Draeger are advising that they are currently producing replacement motors for the potentially affected devices.
Draeger Service has ordered the replacement motors and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange the installation and testing of the replacement motor.
In the meantime, users may continue to use the installed devices. However, it is important to ensure that the instructions, notes and warnings in the relevant Instructions For Use are observed and that the alarms are not disabled on the corresponding Oxygen2 and Nitrous Oxide monitoring devices. Always set gas flows so that at least 21% oxygen is dosed. If the anaesthesia machine drops below the low alarm limit for Fi02 and generates an alarm, please check the settings and adjust them as required.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Stryker has received a higher than expected number of complaints documenting femoral head/hip stem dissociation for certain sizes of lfit anatomic cocr v40 femoral heads manufactured prior to 4 march, 2011.
Action
Stryker are advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40 Femoral Heads should continue to be reviewed as per the protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol.
For further information please see https://www.tga.gov.au/alert/lfit-anatomic-cocr-v40-femoral-heads .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
An internal technical investigation by remel europe ltd, part of thermo fisher scientific, has determined that thermo scientific remel salmonella paratyphi a-h stained suspension (r30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the instructions for use (ifu).
Action
Thermo Fisher Scientific is requesting users:-
Inspect your stocks and remove from further use all units from the affected batch number, then complete the Facsimile Reply Form supplied with the customer letter and fax it to us so that we may arrange for a credit note to be issued. Please complete the Facsimile Reply Form even if
you have no remaining stock which is subject to recall, as we require this information to reconcile this process. Any requirement for review of patient results should be determined by the laboratory director.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Radiometer has recently become aware that the abl90 flex in a very rare specific situation can aspirate calcium solution instead of rinse solution.The specific situation can occur when the following takes place:1. the analyser is in ready mode;2. operator lifts the inlet and then closes it again, thereby initiating a rinse; and3. immediately after lifts the inlet and quickly closes it again.In this situation, it will lead to several parameters reported incorrectly. some of the parameters will not have an error message or question mark indicating a problem with the result.
Action
Radiometer are advising customers:
1. Inform users of the ABL90 FLEX analyser that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyser flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. Users may re-use the same solution pack;
2. It is recommended that users review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1 stated in the customer letter;
Radiometer will release a software solution (SW V 3.4) which corrects this issue. An updated IFU will also be provided to users upon completion of the software upgrade.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a complaint related to akron tilt table middle section frame breakage. the investigation showed that one of the critical welds was missing. not all devices are affected by this defect, however, this issue is seen as a potential hazard and arjo australia seeks to prevent the possibility of any related event occurring again.There was no injury related to this incident.
Action
ArjoHuntleigh is requesting customers:
Complete and sign the Customer Response Form supplied with the customer letter and return this form to the local ArjoHuntleigh office as per the directions given. An ArjoHuntleigh Service person will contact the person you listed on the Customer Response Form to schedule service to verify and (if needed) rework your device, free of charge.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Ortho has confirmed customer complaints regarding the potential for imprecise results when using impacted vitros phyt slides. the results obtained were either positively or negatively biased across the vitros phyt slides measuring range of 3.00–40.00 ug/ml (11.88–158.40 umol/l).To date, no adverse events have been reported as a result of this issue.
Action
Ortho is requesting customers to immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. Ortho will replace remaining inventory of the affected lots or credit accounts.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Getinge has received complaints involving the cardiosave iabps regarding ingress of fluids into the iabp affecting various electronic circuit boards. this situation would prevent initiation or continuation of therapy. to date, getinge has received one report of an adverse event in which one death was associated with a saline spill / liquid ingress.
Action
Getinge are advising that affected sites will be contacted to schedule an on-site service of the Cardiosave IABP to install a protective top cover and perform a System Functional Test.
Until Getinge have implemented the corrective actions above, users should adhere to the instructions outlined on the Customer Letter when using the Cardiosave IABP