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
A software bug has been detected in the cobas integra 800 software version 9864.C2 which affects the execution of routine maintenance of the ise module. the issue is caused by the ise counters in the software being reset to zero whenever the ise rack is removed from the analyser. lf ise service actions and manual maintenance items are not executed at their recommended intervals, there is a potential risk of increased occurrence of calibration flags (slope, sol i dev etc), as well as incorrect and unflagged ise results.
Acción
Roche is currently working on a software fix expected to be implemented by the end of the year. Until the software is available, Roche recommends that operators manually track all ISE counters and to manually request the corresponding Service Action in the Service Software.
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 manufacturer r82 a/s have been informed about breakage of the bolt attaching the handle to the fram on crocodile 3. to eliminate such breakages that lead to the handle falling off they are now using a 8.8 bolt instead of the initial 12.9 hardened bolt. such bolts are now being sent out for retrofitting on units already on the market.This recall action was carried out prior to approval of the recall strategy by the tga.
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 confirmed that the affected advia chemistry systems will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. in cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. if a numerical result is generated with a flag, the ratio will be reported without a flag.
Acción
End users are requested to ensure that all ratio tests should be reviewed for flags prior to approving. Siemen's is developing a new version of software that will introduce a new flag for all ratio results that have a flag on a component test.
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
Leica microsystems is notifying their customers of an important safety issue concerning the ceiling supply units csu 80xx/ csu 60xx, manufactured from 1997 - 2003. the ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approximately 60 cm (23.6 inches).
Acción
Leica Microsystems is contacting their customers to arrange for the complete inspection of the ceiling mount and is providing customers with additional preventative maintenance protocols.
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
Howard wright have conducted testing on a component of the siderail used in the m7, m8 and m9 model beds, and have found a variation in the force required to un-latch the siderail.
Acción
Howard Wright is providing update kits and a replacement procedure to be implemented at annual service by the customers maintenance provider.
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
Affected implants may look darker over some or the entire surface of the implant. this condition is caused by the implant coming into contact with residual machining fluid, which may have been left on the metal packaging insert.
Acción
Biomet 3i is requesting their customers to return any unused product for 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.
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.