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 test kit was assembled containing two components, the wt control and the mu control, that were released for non-commercial internal use only.
Action
Discontinue the use of affected product and dispose them appropriately. There is no requirement to re-test samples tested with the affected product. Roche will be supplying replacement stock when available.
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 alaris pump module may experience intermittent motor stall. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates.
Action
CareFusion is advising users to consider the clinical risk of using these pumps in high risk patients undergoing infusions at high rates and to have alternative pumps available. If a motor stall occurs the users are being asked to quarantine the pump and to contact CareFusion.
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
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
There is difficulty firing the device which may result in an incomplete firing stroke that may result in incomplete staple formation.
Action
Quarantine and return affected product to Johnson & Johnson 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
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.
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
The dash monitor may exhibit an unexpected loss of custom automatic nbp measurement cycling. custom automatic nbp measurement is a feature introduced in dash version 6.0 which allows the user to program up to 4 different nbp auto mode sequences. when a view of another patient with an nbp parameter on the network occurs, if the custom automatic nbp measurement cycling function is enabled, the function will turn off unexpectedly. the issue can occur when manually viewing another bed on the network using the view other beds option or automatically with the automatic view on alarm (avoa) feature.
Action
GE Healthcare is providing users with work around instructions to mitigate the issue. A software update will be implemented to permanently fix the issue when available.
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
Ge healthcare has recently become aware of potential issues with the carescape monitor b850 as outlined below:1. carescape monitor b850 udom failure. it is possible that the carescape monitor b850 may enter into a constant book loop causing monitor to reboot continuously. 2. carescape monitor b850 unstable usb communication. when the usb cable is connected to the cpu or display is insecurely connected or faulty, the monitor may reboot. reboot may also happen if the monitor display is continuously set on and off several times. 3. carescape monitor b850 remote printing issue with currently printing prn 50 recorder. if the recorder prn 50 is busy when the carescape monitor b850 sends a printing request, the printing may not be saved and therefore not printed.4. carescape monitor b850 reboots due to an x server freeze.
Action
GE Healthcare will be implementing a software and hardware correction.
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 is a potential that the analyte comments may be deleted if the specific analyte is not counted in the mask. this risk is avoided in the case that the user makes comments against the “blood film comments” analyte for reporting blood film comments. the differential keyboard orders a profile that contains all of the additional blood cell types that can be manually counted. in many instances these additional cell types will not be identified in the count and will not receive a result (eg blasts, myelocytes, etc). the expected behaviour is that if a cell is not counted, then these analytes will be removed from the profile when the final count is accepted.
Action
Roche is providing work around instructions until a software upgrade can be implemented to permanently fix 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
1) spo2 saturation limit alarm does not always activate when nellcor spo2 is used in pdm and saturation seconds is not switched on.2) when the carescape monitor b650 is started the monitor may enter into a constant boot loop causing monitor to reboot continuously.3) when the carescape monitor b650 is connected to the unity id and information from a 3-lead ecg cable is transferred through dri (s/5) network, the monitor may reboot.4) upgrading the software for carescape monitor b650 may not update the software for power management card (pmc).5) when the usb cable connected to the carescape monitor b650 is insecurely connected or faulty and is able to move the monitor may reboot. 6) carescape monitor b650 remote printing issue with currently printing prn 50 recorder.7) carescape monitor b650 reboots due to an x server freeze. it may reboot when the monitor is viewed from carescape cic pro or when the printing is initiated from carescape cic pro.
Action
GE Healthcare is providing users with work around instructions to mitigate the issue. A software and hardware update will be implemented to permanently fix the issue when available.
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 is the potential for foil degradation on the dgp-hp rfa high power single use grounding pads. this foil degradation may result in an electrical disconnect and an undesirable thermal profile during use which may result in a patient burn at the pad site.
Action
Covidien is recalling the affected lots and replacing it 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
Anomalous decreases in the average optical density (od) have been observed with certain kits within the lifecodes pak product line. the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.
Action
Quarantine and discard affect products. The sponsor recommends reviewing past valid assay runs and compare Positive Control values obtained with recalled kits against historical trend data and discussing results with healthcare providers to determine if any further testing is 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
The following issues have been identified with this product:1. the current system design of software version 4.0.0.Xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for ct brain perfusion scanning, which previous versions did. however, the current version does have the dose check (nema xr-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable dose check after entering their credentials and password 2. when service providers gain a remote connection to the scanner, the scanner does not notify the user that remote access of the system is in effect3. when the interventional biopsy protocol is used, the manual button is enabled on the ct control, but when the user presser the "go" button on the gantry, it may produce multiple scans4. the table and the gantry could get close enough to each other (<25mm apart) which poses the risk of 'pinching' a patient's or technologist's finger.
Action
Philips is providing a software update to permanently correct the issues.
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
Kerr australia advises that the current directions for use for tempbond ne lists a working time that is not indicative of the actual performance of the product. more specifically, the current directions for use lists the total working time as 90 seconds, while the material actually provides a minimum working time of 60 seconds.
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
Reports of heating at the ipg implantation site during charging of the spinal cord and deep brain stimulators. this is an update to the 'hazard alert' letter dated 05 january 2012 . in the updated letter, st. jude is providing updated occurrence rates, informing hospitals and treating clinicians of four instances of patient burns associated with charging the ipgs and additional patient management recommendations.
Action
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please see 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
Biomet spain orthopaedics s.L. has initiated this action following the investigation on a reported event. it has been confirmed that in a few cases the affected product does not properly fit in the acetabular cup.
Action
Biomet Australia is contacting the treating/implanting surgeon regarding the issue so that the affected patient can be appropriately managed.
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
A customer complaint reports that the article 022.2630 nc screw for cares® abutment, zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 nc screw for cares® abutment, zr02 and ifu incorrectly contain an rc screw and 022.4630 rc screw for cares® abutment incorrectly contain an nc screw. all of the affected lots are identified and stopped further shipment however the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 cares® abutment set rc, ceramic and 87 cases 027.2650 cares® abutment set nc, ceramic and dental laboratory.This recall action was not notified to the tga before it was initiated by straumann pty ltd.
Action
Quarantine and return affected product to the distributors.
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 use of the disposable general purpose 9 french temperature probe for nasopharyngeal applications can create, in certain clinical conditions, a potential for severe epistaxis, which may require interventional procedures or prescription medications to properly resolve. these clinical conditions include patients treated with anticoagulants or are at risk for coagulopathy.
Action
GE Healthcare is recalling all probes and will be replacing them (or providing credit) with new sterile units solely to be used for oesophageal or rectal use and are updating the 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.
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
There have been reports of leaking injectors on the empty sterile vial. hospira's investigation concluded that injectors had a manufacturing defect in the promixal 'adhesive well' area due to a weak adhesive bond. the injectors accompanying the empty sterile vials may have an increased risk of leaking, particularly during the filling process.
Action
The sponsor is providing work around instructions to mitigate the risk.
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
Tga's microbial testing of l-gel ultrasound transmission ge shows general microbial count exceeding the microbial standards for medicines (tgo 77) that are intended for cutaneous and mucosal use. such microbial levels constitute a moderate to serious health hazard for infection, especially if the ultrasound transmission gel is used for a non-intended purpose, e.G. an invasive procedure.
Action
Customers to remove stock from use and contact the sponsor to arrange return of product. For more details, please see http://www.tga.gov.au/safety/alerts-device-l-gel-120816.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
Siemens has confirmed analytical sensitivity of greater than the 0.3ng/ml described in the instructions for use with multiple advia centaur prolactin reagent lots and multiple calibrator b lots when run on the advia centaur cp only.
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
Five customer complaints have been received regarding the appearance and performance of the scalpel blade. the customers have complained that the product is sub-standard and unsatisfactory. samples of the device in question were examined and the product was deemed sub-standard.
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 single prong bracket that attaches to the headrest has broken on two occasions. this resulted in the headrest falling off the product.
Action
Doability is recommending users to implement a work around until replacement brackets can be installed on all affected 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
Siemens confirmed analytical sensitivity values greater than 0.3mlu/ml described in the instructions for use when evaluating multiple lots of the advia centaur fsh assay and calibrator b on the advia centaur and advia centaur xp system.
Action
Siemens is providing work around instructions for users to follow.