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.
Notas adicionales en la data
Causa
Biomet 3i has received a number of reports relating to bellatek zirconia abutment fractures. the device is fracturing at a higher than acceptable rate.
Acción
Affected customers are requested to return any BellaTek Zirconia Abutment cases to Biomet 3i for replacement with an alternative product or full credit.
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.
Notas adicionales en la data
Causa
There are artifacts appearing on the tracker images during threshold-triggered bolus scans with protocols using a rotation time of 0.4 seconds. in those cases only, the scan might be triggered either too soon or too late, which may lead to inappropriate contrast opacification during the clinical scan. if the acquired images are not diagnostically acceptable, a rescan of the patient need to be performed.
Acción
Clinical judgment should be used by the customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis. Philips Healthcare is implementing software update version 3.6.2 to 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.
Notas adicionales en la data
Causa
Philips received a report from the field that the flat panel detector (fpd) sensor reported to the operator that the panel was unlatched at the 0 degree position during setup. the operator attempted to manually relatch the fpd as it remained in the 0 degree position. in trying to restow the fpd, it fell from its stowed position and contacted the patient's leg and the technologist's arm.
Acción
Philips Healthcare is advising their customers to only deploy or stow the FPD when in the +90 degrees position. Philips will be implementing a field correction to prevent the issue from occurring.
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.
Notas adicionales en la data
Causa
Maquet cardiopulmonary has determined that in certain rare instances the cardiohelp-i device may display an error message with audible alarm indicating "battery defective". the alarm will occur while booting or when the main power supply is unplugged from the main power source. this is due to a defective capacitor within the battery manager board. further, when alarming the hmi (human machine interface) will gradually become black due to the hmi back light shutting down.
Acción
Maquet is advising the customers to only use the Cardiohelp-I on AC power when possible. In the event of a battery defect alarm the AC power should be connected immediately. An upgrade to the sensor panel will be carried out to 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.
Notas adicionales en la data
Causa
Grifols australia is undertaking a recall due to a potential finding of higher than expected number of cards with wells showing incorrect level of supernatant or cracked gel when they perform the intiial visual check of the cards as stated in the instructions for use. the origin of the problem is a production incident in the card sealing process where some cards were incorrectly sealed. this issue will induce supernatant evaporation that finally will lead to incorrect supernatant levels or cracked gel.
Acción
End users are requested to quarantine all stock from the affected lot and contact Grifols to arrange for replacement stock. Once replacement stock has been received end users are requested to discard the affected lot in their biological waste.
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.
Notas adicionales en la data
Causa
Baxter has determined that the product pouches for the affected lot numbers may have tears potentially causing a breach in the sterile barrier.
Acción
Baxter is requesting their customers to return all 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.
Notas adicionales en la data
Causa
Internal testing has identified that the one-way check valve (pillow valve) included in the fms outflow tubing set and the fms intermediary tubing set may occasionally not be performing as intended. if the instructions described in the fms duo system and solo system operator's manuals are not followed, this may result in backflow of irrigation fluid into the "one day" set, and when used with affected tubing, could potentially lead to patient cross-contamination. please note that the backflow of irrigation fluid can only occur if the check valve is not working properly and the pressure line is disconnected or the tension rocker is open.
Acción
Customers are asked to quarantine any affected stock and return it to JJM. Customers are also advised that when connected properly and used in accordance with the system’s Operating Manual, tubing with an affected check valve will not allow backflow of irrigation fluid into the One Day Set, and would not lead to potential patient cross-contamination. It is important to follow up with potentially affected patients per each institution’s Infectious Disease/Needle stick protocol.
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.
Notas adicionales en la data
Causa
Zimmer recently conducted a review of historic packaging validations completed. based on this review, it was determined that a subset of product packaged at a single zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. this testing determined that a single packaging tray configuration used for versa-fx ii femoral fixation system, which consists of an inner and outer sterile tray, failed the leak test due to damage in the corner of the inner cavity.
Acción
Zimmer is requesting hospitals to inspect the packages as described in the device package insert. If a inner package is determined to have been compromised, the device is to be quarantined and a Zimmer sales representative contacted.
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.
Notas adicionales en la data
Causa
The sleeve tube of the ureterorenoscope may break off when being used. this problem only occurs with specific serial numbers, one of which was supplied in australia.
Acción
Endocorp is advising their customer to quarantine the affected unit. A replacement ureterorenoscope will be provided.
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.
Notas adicionales en la data
Causa
Ge healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the engstrom ventilator and the aespire view, aisys and avance anaesthesia machines. as a result of a manufacturing issue, the buttons on the left, right and bottom keypads may not always detect button presses. this may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
Acción
The user may notice that a button press may not actuate the desired function. Usually by pressing the key again, the device will respond as expected. If a button has no response, the menu function may be accessible through the use of the control wheel. If none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative. GE Healthcare will correct all affected systems.
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.
Notas adicionales en la data
Causa
Detailed investigations have confirmed a deviation in the hba1c result in the range of -10% to up to -30% from the target value with an error rate of up to 40%.
Acción
Roche is requesting their customers to discard any affected HbA1c. Destroyed product will be replaced with new stock once it is 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.
Notas adicionales en la data
Causa
Customer complaints reported that the smarttouch catheters were not irrigating correctly during ablation and often resulted in temperature increases and generator shut-off. an internal investigation identified that there is polyimide delamination of the inner lumen surface that can lead to occlusion of the irrigation fluid lumen. insufficient or lack of irrigation (occlusion) can potentially increase the risk of char or thrombus formation at the tip of ablation catheter, which may lead to thromboembolic events, such as stroke.
Acción
Customers are asked to quarantine the affected product remaining in the market and return it to Johnson & Johnson Medical Pty Ltd.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
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.
Notas adicionales en la data
Causa
Under certain conditions, x-ray release on artis system version vc1x may get blocked. thepotential malfunction may only occur if:a) the system is ready for operation, andb) the c-arm was moved into the so called "patient transfer position" for patient transfer (in this position x-ray is blocked), andc) at the same time the c-arm is in "patient transfer position", a hardware failure in the ias (image acquisition system) is occurring.If the c-arm is moved out of the "patient transfer position" (the problem with the ias was solved by the system itself), x-ray remains blocked.This issue is known to have only occurred on a single system in the field.
Acción
If the failure mode occurs, customers are advised to urgently manually switch the system OFF ("System shutdown") then switch the system back ON again. The failure mode cannot be generally rectified by either executing the "System Restart" or "Application Restart" functions. The supplement to the Operator Manual with the above information is enclosed with the customer letters. The problem will be resolved during the next service 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.
Notas adicionales en la data
Causa
Investigations have determined that the affected lot numbers may yield an increased number of false-positive results. performance testing has concluded that there has been a shift in the sero-epidemiology of the patient population currently being tested. use of this product on an automated system may further increase the proportion of false positive results.
Acción
Alere is requesting their customers to discontinue and destroy all remaining affected lots. Replacement product is expected to be available in 1 - 2 weeks. Customers are advised to consult with their resident clinical expert or doctor, if they question any previously reported results.
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.
Notas adicionales en la data
Causa
Carestream health australia has received reports from overseas of unusable diagnostic images on exams where a normal exposure mode (nem) view is exposed immediately prior to an extended exposure mode (eem) view with the system in fast preview mode.
Acción
Carestream Health Australia is providing a firmware update that will allow NEM and EEM images to be taken in any order. The update will be provided at the next scheduled service or within 3 months. Until the firmware upgrade is installed end users are advised to only perform the EEM acquisition prior to the NEM acquisition.
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.
Notas adicionales en la data
Causa
The instructions for use was updated to address the increasing use of disinfectants containing alcohol and/or acetone to clean vascular access devices. the use of these disinfectants can cause damage to the polyurethane contained in the catheter and make it more susceptible to physical damage, which may ultimately lead to the need to replace the catheter.
Acción
Covidien has updated the instructions for use for polyurethane single lumen umbilical vessel catheters to include additional information on the care of the device.
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.
Notas adicionales en la data
Causa
Internal testing has confirmed customer complaints regarding an upward shift in qc and patient results following calibration with loci cardiac troponin i calibrator lot 3dd007. based on initial internal investigation, siemens estimates that approximately 40% of the calibrator lot is affected. internal testing on patient samples demonstrated an average upward shift of 24% range when compared to an unaffected lot.
Acción
Siemens is requesting their customers to immediately discontinue use and discard any remaining inventory from the affected lot. Siemens is recommending to discuss the issues and requirement for retesting with the medical director. The recommendations regarding the need to review previous QC and patient results is limited to samples tested within the past 24 hours.
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.
Notas adicionales en la data
Causa
Medtronic has identified a labelling issue for lot number 207002011 of the nc sprinter rx balloon dilatation catheter, model ncsp22512x, in which the compliance chart contained inside the package incorrectly references a 2.5mm balloon diameter instead of the correct 2.25mm diameter. if the affected product was utilised referencing the incorrect compliance chart, the target diameter of the balloon may be less than expected, resulting in suboptimal treatment. the situation would require further inflation at a higher pressure or the use of another balloon catheter to resolve the stenosis, resulting in longer procedural duration.
Acción
Medtronic is requesting users to return affected stock for replacement with unaffected product.
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.
Notas adicionales en la data
Causa
Bd has determined that affected bbl mgit tubes were labelled with an incorrect barcode, such that the correct barcode prefix "43 01" was actually printed as "43 02". the manufacturer identified this error prior to supplying the product and over labelled the product with the correct barcode. the manufacturer has identified that the over labels may peel off in varying degrees which exposes the incorrect barcode. this can result in mgit false negative results.
Acción
BD is requesting users to discontinue use and discard any remaining inventory of the affected product. Replacement stock will be provided by BD. The package insert recommends that users perform a visual check of all instrument negative tubes. Tubes that appear to be positive should be sub-cultured, acid-fast stained and treated as a presumptive positive. A review of previously reported results is not required if this protocol is followed.
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.
Notas adicionales en la data
Causa
If the tension screw present in the mounting yoke of the vision mounting arm is loose and the user applies excessive force during positioning, the user can push the monitor out of the yoke. this will cause the monitor to dislodge from the mounting arm and fall potentially impacting an operator or patient.
Acción
Stryker is advising users that a new screw and washer will be installed on all affected units to ensure the monitor is securely fastened to the mounting yoke. It is expected that this will be completed by April 2014.
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.
Notas adicionales en la data
Causa
Invacare has identified a defect in a small percentage of crimped wire connections in certain joysticks which could result in oxidation leading to the slowdown of wheelchair speed performance over time. in a very small percentage of instances, the power wheelchair may slow down relative to the commanded speed and then recover, creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects, which can lead to bruising, pinched fingers, and pinched hands.
Acción
Invacare is providing distributors with two options to correct the affected joystick. 1) Invacare will supply the distributors with the correction kit for each affected joystick, with instructions on how to return the affected joysticks to Invacare. 2) Invacare will engage a third party to complete the correction. Distributors are required to provide the details for end users to the third party in order to correct the affected joysticks. Invacare will correspond with end users directly if this option is selected. For more details, please see http://www.tga.gov.au/safety/alerts-device-invacare-131011.htm This action has been closed-out on 11/04/2016.
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.
Notas adicionales en la data
Causa
Following a customer complaint it has been determined that some information in the surgical technique guide and application notes on the proximal screw angle and plate thickness is incorrect. a revision has been made to the surgical technique guide and the application notes to correct this error.
Acción
Synthes is notifying hospitals of the error and is providing updated Surgical Technique Guides 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.
Notas adicionales en la data
Causa
Nx3 try-in gels allow for the restorations to be seated temporarily for review of their final appearance prior to cementation. kerr australia have received reports that some nx3 try-in gel syringes in the affected lot incorrectly contain a polishing paste. as the material in the affected syringe does not match the shade of the cement as it is labeled there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration colour requiring the need to remove and repeat the restoration.
Acción
Kerr Australia is requesting customers to stop using the affected product and return to Kerr Australia for replacement or credit.
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.
Notas adicionales en la data
Causa
Siemens has determined that not all distributed lots would meet the performance criteria as currently described in the instructions for use (ifu) with respect to the analytical sensitivity. siemens are updating the labelling to better reflect the observed and potential range of assay performance with respect to this parameter (i.E less than and equal to 2.0 iu/ml).
Acción
Siemens is providing work around instructions for users to follow until the revised Instructions for Use (IFU) are released.