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
Some heartstart mrx monitor/defibrillators may contain compromised electronic components and present the following behaviours:·in automatic external defibrillator (aed) mode, the mrx may have difficulty interpreting the pads ecg waveform. the mrx may incorrectly analyse the rhythm or may fail to analyse the rhythm.· in manual defibrillation mode, if the pads/paddles ecg signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.· when using q-cpr measurement and feedback, the feedback on ventilation rate may be inaccurate.
Action
Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions.
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
Boxes of discovery trays marked to contain child-sized and small-sized trays actually contain adult-sized trays.
Action
Kerr Australia is asking users to return the affected products.
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
The manufacturer has advised that affected devices were labelled with an incorrect expiration date of 48 months instead of 36 months.
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
Otto bock healthcare gmbh has received a number of complaints that the adapters have shown signs of cracking during assembly or fitting. on two occasions cracks developed after the prosthesis was used for a short period of time.
Action
Quarantine and return affected devices to Otto Bock Australia
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
Packages labelled as long-handle cutters actually contain short-handle cutters.
Action
Return affected lots to Ormco for replacement with unaffected stock.
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
Issue 1: the carabineer used to attach the spreader bar to the lifter may show some wear in the case of intensive or severe use. issue 2: during operation by customers, the spreader bar may unintentionally unhook from the carabineer.
Action
Issue 1:
Invacare has informed that they will check and replace the carabineer if the thickness of its sections measures less than 6mm.
Issue 2:
Invacare has developed retrofit kits and are intending to address this issue by reworking all the affected units.
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
Some patients experienced gradual wear of their insulin pump keypad that led to damage such as tearing or peeling of the edge of the keypad from the insulin infusion pump. the buttons may not respond as intended. the potential hazard is that it may cause the pump to malfunction and may cause under infusion or over infusion of insulin, resulting in hyperglycaemia or hypoglycaemia respectively.
Action
Customers are requested to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of inspecting the pump. The Sponsor will replace any pumps that have a confirmed issue with the keypad.
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
Hemocue has become aware of indications of in-correct high readings of hemocue glucose 201 rt and hemocue glucose 201 dm rt for the application of monitoring of blood glucose levels on pre-term neonates. on full-term neonates there are no similar indications but as a precaution hemocue has decided to replace all systems on delivery and neonatal wards with hemocue glucose 201+ or hemocue glucose 201 dm while investigations continue.
Action
HemoCue is recalling affected devices and is replacing them with unaffected models
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notes supplémentaires dans les données
Cause
This is an update to hospira’s previous safety alert notice (tga ref # rc-2011-rn-00812-3) concerning the gemstar docking station. at that time, hospira had received reports from customers of sparking, smoking, charring and electrical shock when using the gemstar docking station. hospira’s investigation concluded that the primary root cause was related to the potential for fluid ingress into the docking station. the design improvements have now been finalised and hospira is replacing all existing docking stations with the new design.
Action
Customers to advise Sponsor of the number of docking stations held and they will be replaced with the newly designed units.
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
If multiple uncompressed images/clips are sent to the syngo dynamics server around the same time, it is possible for an image from a patient to be placed in another patient's study. the dicom data may belong to the correct patient, but the pixel data may belong to another patient.
Action
Siemens is providing work around instructions until a software fix can be implemented to permanently correct the issue.
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
Ev3 have issued update to the instructions for use (ifu) to inform physicians and patients about the risk of catheter entrapment associated with the use of onyx liquid embolic system (les).
Action
Updated Instructions for Use (IFU) is being provided to the customers.
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
The manufacturer has identified that in some situations a miscalculation may occur for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in these functions is not correct for images with a pixel depth greater than 12 bit. the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.
Action
Siemens is providing work around instructions until a software update can be implemented to permanently fix the issue. This action has been closed-out on 18/02/2016.
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
The manufacturer has identified that in some situations a miscalculation may occur for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in these functions is not correct for images with a pixel depth greater than 12 bit. the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.
Action
Siemens is providing work around instructions for each issue and will be implementing a software update to correct the problem.
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
The current directions for use (dfu) for extrude wash lists a working time that is not indicative of the actual performance of the product.
Action
Kerr Australia is providing updated Instructions for Use (IFU)
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
1) axis-shield poc as, the manufacturer of afinion crp system, warns that an information code (error code) which is displayed on the analyser screen might potentially be misinterpreted as a high crp result. 2) the crp concentration in frequently opened control vials may increase due to evaporation. therefore, the stability of opened vials of afinion crp control has been reduced from 8 to 4 weeks.
Action
Alere is providing work around instructions and will be implementing a software update.
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 confirmed a decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems. this under-recovery has been observed in plasma samples with high bnp and tsh-3 values that require dilution to achieve results within the reportable range on the advia centaur and advia centaur xp systems.
Action
Siemens is providing work around instructions for users to follow.
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
Alaris pump module model 8100 that contains the door assembly with keypad part number tc10005926 may be at risk of the door keypad overlap separating from the keypad assembly. when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm.
Action
The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units.
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
Beckman coulter has confirmed that the stability, while frozen, for the access folate calibrators may produce falsely elevated results which could mask a folate deficiency. product number a14207 may experience this issue at 12 months, and product number a98033 at 6 months.
Action
Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications.
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
The forceps inside the packaging may be the incorrect configuration. specifically, the outer packaging indicates the product is dbf-2.4sn-230-s (has non-spiked forceps head), but the forceps inside are actually dbf-2.4sl-230sp-s (has spiked large forceps head).
Action
Quarantine and return affected devices to Cook Medical.
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
This is an update to the 'hazard alert' letter dated 24 may 2011, pertaining to the eon mini model 3788 and brio model 6788 implantable pulse generators (ipgs) inner battery cracking issues. st. jude medical received reports eon mini and brio ipgs that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.
Action
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please refer to the TGA Website http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm
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
Three issues requiring correction have been identified by the manufacturer:1. during reliability tests on the steel rope, one of the springs broke and the safety catch did not hold. the safety catch mechanism does not activate due to the counteracting force of the remaining spring. as a consequence the u-arm moves down uncontrolled. the manufacturer has identified that this can occur in the field earliest after 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system. 2. during installation all 3 screws for one sib chain wheel were found loose. if all 3 screws of one of these wheels loosen completely, the detector carriage and/or the tube carriage can move down uncontrolled until stopped by the corresponding end stop.3. during in-house testing it was detected that the life time of the wire rope is significantly lower than the specified 10 years. the replacement of the wire rope every 3 years is required.
Action
Philips is urging customers to contact them if they have any concerns and is replacing the vertical carriage, wire rope, SID chain wheels and 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
Monitoring and analysis of the clinical results of the smr l2 metal back glenoid component indicate that under certain conditions, for example rotator cuff failure or patient trauma, the polyethylene insert can disassociate. the total revision rate of the l2 version of the smr metal back glenoid component in australia is 6.78% at three years.
Action
Lima is contacting all implanting/treating surgeons and advising them on how to manage patients implanted with the L2 component. For more details, please see http://www.tga.gov.au/safety/alerts-device-shoulder-smr-121030.htm .
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
The agility beam limiting device (bld) does not support the use of dynamic multileaf collimator (dmlc) apex at this time. apex has not been integrated or classified as compatible for use with the agility. the use of these products together has not been verified or validated by elekta and they must not be used together. there are mandatory changes necessary to the agility bld interlock circuit to let you safely attach the apex device.
Action
The customers are advised not to use Apex with Agility as the combined use could cause fatal injury, clinical mistreatment or damage to the equipment. At this time, it is noted that no Australian customers currently have an Apex installed.
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
There have been reports concerning quality control results outside of the expected ranges. siemens has determined that this issue is due to a decrease in the onboard stability of the ehv assay reagents. this issue will be identified by the quality control material.
Action
Siemens is providing work around instructions for users to follow.
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
While performing a fluoroscopic acquisition with the innova 2121iq or innova 3131iq systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. it may happen in a very specific scenario when one operator is requesting a lih (last image hold) functionality and another operator starts a short fluoroscopy exposure (stopping fluoroscopy exposure within 2 seconds) without waiting for the display of the lih (last image hold) in review monitor. the user would need to restart the system in order to regain acquisition capability.
Action
GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue.