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 2013 annual report of the national joint replacement registry (njrr) indicates that up to december 2012, the cumulative percent revision of the msa hip system has been calculated as 6.2 % at one year and approximately 11% at 2 years , both of which are significantly higher than that of other hip replacement prostheses. the most common reasons for revision of msa to date have been loosening/lysis and peri-prosthetic fracture, but there have also been a few revisions due to prosthesis dislocation, pain and infection.After consultation with the therapeutic goods administration, a decision has been made by global orthopaedic technology to cease supply of the msa hip stem. this device has been removed from the australian register of therapeutic goods.
Acción
Global Orthopaedic Technology is informing implanting surgeons that it is advisable for annual clinical and radiological examinations to be performed on patients who have been implanted with this device, in accordance with routine patient post arthroplasty care. For more details, please see http://tga.gov.au/safety/alerts-device-msa-hip-system-140703.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.
Notas adicionales en la data
Causa
Testing by therapeutic goods administration (tga) has identified sterility failure for the batch number: 050713hf. samples tested by the tga have identified the presence of bacillus pumilus. the use of contaminated bandage is a potential safety concern especially when used on open wounds. no other batches of crepe bandages are supplied in australia.
Acción
If customers are holding the affected batch number, please discard any single units and unopened cartons should be returned to Clifford Hallam for full credit. 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.
Notas adicionales en la data
Causa
Mckesson has identified a rare software issue when two or more processes attempt to modify the same image folder within fractions of a second, the write lock mechanism may fail to prevent concurrent modification of the same data. this may result in loss of data within the image folder. as both simultaneous write access and lock mechanism failures are rare, the likelihood of experiencing this problem is very low.
Acción
The manufacturer, McKeeson Medical Imaging, will provide a software update to resolve this issue. Until the issue is resolved end users are advised to ensure that all expected images are present in a study prior to completing the Technologist workflow. Thia action has been closed-out on 28/01/2016
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
It has been identified that a small number of low & micro flow lancet needles of the batches listed fail to retract completely within their casing after use. improper handling of the device in these instances poses a risk to the user.
Acción
Linear Medical is requesting their customers to discard any remaining single units of product and return any unopened boxes 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
Ormco corporation received a complaint that the product labelling descriptor on the package for damon tma low friction archwires references dimensions that are different from those of the actual wire. the label states that the wire dimension is .017x.020, however the actual dimension is .017x.025. although the product description on the label is incorrect, the part number, lot number, product packaging and the product within the package are correct.
Acción
Ormco is advising their customers to be aware of the incorrect information on the package labels.
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 is initiating a hazard alert for specific lots already implanted due to the potential that the threads may be out of specification. zimmer received twelve complaints over a period of two and a half years alleging difficulty threading an mis drop down stem extension or a drop down stem plug into the mis stemmed tibial component. there were no complaints received from australia. the potential risks for this issue are: · additional bone loss may occur if the mis tibial is cemented in place when the issue is identified and the surgeon elects to remove and replace.· early revision may occur due to loosening (if the mis stemmed tibial component is implanted without a drop down stem extension), and/or infection.· disassociation of the implanted articular surface may occur if the stem extension does not fully seat, thus causing the articular surface to not properly lock.
Acción
Zimmer is providing surgeons with details of the potential risks associated with out of specification thread. For patients implanted with a potentially affected device, Zimmer recommends continued normal post-operative follow-up. For more details, please see http://www.tga.gov.au/safety/alerts-device-nexgen-complete-knee-solution-140709.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.
Notas adicionales en la data
Causa
Varian has seen a trend in reports of unexpected decrease in beam output in c-series high energy linacs for 6mv photon treatment mode. varian has determined the cause of the unexpected variations in beam output to be degradation of the 6mv target. specifically, the effects of modern, highly modulated treatment modes can create high levels and frequency of stress cycles in the targets particularly if the beam spot size is small. this can lead to the targets' deterioration and failure at an accelerated rate resulting in a rapid change in the beam output and symmetry. specifically:1. the photon generation, or bremsstrahlung yield, decreases as fewer electrons are converted to photons in the target, and;2. due to a resulting escape of primary electrons the output of photons, as measured by the ion chamber, might appear to be constant, but the actual photon output is decreasing.This failure mode in the target only affects the 6 mv photon treatment modes (6srs, 6fff and 6x).
Acción
Varian strongly recommends that all sites implement daily output constancy checks of
photon beams as recommended by the AAPM. Specifically those provided by:
1. AAPM, Task Group 142 Report: Quality Assurance of Medical Accelerators, Medical
Physics publication 36 (9), September 2009, and
2. AAPM Report No. 46, Comprehensive QA for Radiation.
It is particularly important that these daily output constancy checks include all 6MV beams
[6SRS, 6FFF and 6X]. Sites should particularly check for any sudden decrease in dose
output = 3% per day, or =6% per week.
If any sudden decrease in dose output is observed, cease use of all 6MV beams and contact Varian immediately. A Varian service representative will visit the site and investigate whether the target is degrading, or has failed.
A technical fix is planned for implementation in a future Clinac system control software release.
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 is an error in the expected values chart pertaining to the level 2 ph control range for all siemens blood gas instruments. due to this error, the recovery of ph for rapidqc complete, level 2, lot number 362303, is elevated. it is also possible that some instruments may, on occasion, recover ph out of range high. however, the published target ranges for all other analytes are unaffected.
Acción
Siemens is providing their customers with the correct pH range assignments (in pH and H+ units) and corresponding barcodes for all the Siemens blood gas systems. End users are requested to re-enter the corrected pH target ranges, or rescan these barcodes into the blood gas system to replace the ones in the Expected Values Chart and keep this notice with the control material.
Repeat testing of any patient samples is at the discretion of laboratory.
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 is conducting a recall of the above mentioned blood collection tube due to poor separation resulting in a reduced number of recovered mononuclear cells. having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection, potential delay of treatment, and in remote cases, could lead to erroneous results.
Acción
BD is requesting their customers to check their inventory and quarantine product subject to this recall. BD will arrange for the collection and replacement of all affected 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.
Notas adicionales en la data
Causa
As a result of an internal investigation by trinity biotech, it has been determined that the symbol to denote 'harmful' has been omitted from the package insert. the information within the package insert regarding tha handling and disposal of the product is still correct. if the package insert and msds is followed correctly there is no risk to the end user when handling or disposing of the kits.
Acción
Immuno is advising their customer that the product was supplied without the appropriate symbol to denote "Harmful". End users should be aware that all the information within the package insert is correct including handling and disposal 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.
Notas adicionales en la data
Causa
Abbott molecular has identified that the system liquid sensor and liquid waste sensor on the m24sp instrument system may be disabled due to an issue with the m24sp application database. if the system liquid sensor and liquid waste sensor are disabled, users will not be notified by the m24sp that the system liquid container needs to be filled or that the liquid waste container needs to be emptied.
Acción
Customers are advised that if they follow the Daily Maintenance and Operating Instructions within the m24sp Operations Manual there will be no impact as the containers are large enough to hold sufficient amounts of system liquid and liquid waste for daily use. A Field Service Representative will ensure that the System Liquid and System Waste sensors are enabled during installation of Application Database version 7.0.
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
This action is taken to inform users of a change in the instructions for use related to the proper use of the lubricant oil (ptx-of-z11) applied on the ptx-of-b130 and ptx-of-b194 gas/water feeding valves, as supplied by pentax medical.The pentax brand silicon oil ptx-of-z11 must always be used for the o-rings of pentax gas/water feeding valves. at this time, pentax medical can only recommend ptx-of-z11 as it is the only lubricant validated by pentax medical for use with these valves. if other oil were applied to the o-ring of ptx-of-b194 this may impact the functionality, and it may cause uncontrolled, continuous gas flow or excessive gas insufflations, resulting in a patient injury such as pneumatic perforation or gas (air) embolism.
Acción
Device Technologies is providing updated Instructions for Use with the customer letter. Users are also advised that If the valve does not function properly (does not move smoothly, feels sticky, leaks air or water) remove it and inspect for worn or damaged O-Rings. Replace O-rings as necessary. In case the valve does not function properly during an examination, stop CO2 or water supply at the primary valve (i.e CO2 insufflator or CO2 bombe) immediately.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There is a potential issue with the qube compact monitors that are “docking station ready” that have had a port cover plate removed allowing the monitor to be used with the optional qube docking station. if a docking station ready qube monitor is powered up undocked, connected to the network via an ethernet hardwire connection, and then disconnected from the ethernet hardwire connection and inserted into a qube docking station, a switch condition will cause the monitor to lose the network connection. all bedside alarms will continue to function normally.
Acción
If the users dock the monitor and lose network connection, power down the monitor and turn it back on to restore normal function. To prevent this error from happening, users are advised to avoid transitioning from hardwire ethernet connection to a docking station without powering down the device. Medtel Pty Ltd will contact affected sites to schedule a convenient time to correct the sites affected qube monitors.
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
Hill-rom would like to remind users of proper handling of the lift-off foot section per the affinity four birthing bed manual. improper handling, such as allowing the foot section to be dropped repeatedly, could cause the attachment latch mechanism to become bent. if the latch mechanism is bent badly enough, it could potentially cause the installed foot section to be improperly engaged onto the bed. if the damaged foot section should disengage during use, this could result in injury to the user due to a fall.
Acción
Hill-Rom is highlighting key instructions in the operator's manual and providing additional instructions to end users to verify if the Lift-Off foot sections have enough engagement. A change to the Lift-Off foot section is currently in development to mitigate the issue.
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
Wallac oy, a subsidiary of perkinelmer, has become aware that extended exposure to the ioniser pins of the panthera-puncher 9 can decrease the reaction signal level of assays using antibody coated microtiter plates (such as immunoassays). wallac oy's investigation has shown that uncoated plates are not affected by the phenomenon (such as enzymatic assays). the phenomenon has been determined to be localised to those wells that are located beneath or adjacent to the ioniser pins when the panthera-puncher 9 is idle or in sleep mode. the software allows the ioniser to remain active when the puncher is idle or has gone into sleep mode. the impact on health is dependant on the assay and the associated disorder the assay screens for in the dried blood spot sample.
Acción
PerkinElmer is advising end users to remove plates from the Panthera-Puncher 9 when not actively punching and processing samples. If plates must reside in the device the plate track hatch should be opened to disrupt power to the ioniser. A PerkinElmer Representative will contact customers to arrange for inspection. Additionally, a software update is under development that will automatically switch off the ioniser when the device is in idle. This action has been closed on 29/01/2016.
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
Through the investigation of the complaints, cordis and creganna-tactx have observed that the balloon of the affected product, which is covered with a hydrophilic coating, may exhibit resistance to the removal of the balloon cover. weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. use of a weakened catheter may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. there is no concern for patients who have already been treated successfully with the affected product.
Acción
Johnson & Johnson Medical is advising end users that if unusual force is required during the removal of the shipping stylet and/or balloon cover, the unit is not be used. This warning is also being added to the product labelling.
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
Origio has identified a 'pinhole' packaging breach on the 3-pack pouched version of the pasteur pipets. as a result, the sterility of the package cannot be guaranteed.
Acción
Origio is requesting end users to return the affected lots of pastuer pipettes to their distributor 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
Johnson & johnson medical pty. ltd (jjm) is notifying surgeons of a change to the surgical procedure for all lots of reclaim taper sleeve protector because the product can be difficult to remove from the distal stem both before surgery and after proximal reaming.
Acción
Johnson & Johnson Medical is advising surgeons to remove the Taper Sleeve Protector prior to implantation of the RECLAIM Distal Stem. JJM will remove the Taper Sleeve Protector from future Distal Stems.
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
Two lots of 3m espe filtek supreme xte flowable restorative (ginseng) have been mislabelled. product labelled a2 shade contains a3.5 shade restorative material, and product labelled a3.5 contains a2 shade restorative material. 3m australia has advised that there is no health or safety hazard associated with this product.
Acción
3M is requesting its customers to place the product on hold and return any affected 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
Stryker has received complaints from the field regarding intouch beds, which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. these broken casters are identified when the intouch beds are hoisted or lifted from the floor during regular maintenance. if more than one caster on a unit is damaged, brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged, brake functionality continues to meet specifications.
Acción
A Stryker representative will perform an onsite inspection to determine if casters are affected. If affected the casters will be replaced. End users are reminded to not use the electronic brake to slow or stop the bed while it is in motion.
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 confirmed that some vials within some boxes of this batch may fail to support the growth of clostridium sporogenes. continued use of this lot could result in failure to detect this or similar anaerobic bacteria. the medium was found to still support the growth of all aerobic bacteria tested.
Acción
Oxoid Australasia is requesting their customers remove any affected stock from further use. Arrangements will be made for replacement or credit note to 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
Stryker has received reports of fracture of the vertebral peek spacers when implanted with the avs aria implant inserter. according to the reported complaints, the proximal end of the implant either cracks or the tip breaks off in one fragment. there have been no reports of the broken fragment remaining in the surgical site.
Acción
Stryker is advising their customers to quarantine any affected lots and will arrange for the return of any affected lots from the field.
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
Mckesson has identified that its communication to customers regarding the required maintenance tests was insufficient. while each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 hf4 and earlier versions of the horizon cardiology hemo user guides. if the parameter boxes are not calibrated, the horizon cardiology hemo system may not function properly or potentially affect the accuracy of clinical parameters.
Acción
Users are advised that the new version of the User Guide (12.2 version 5.0) is now available to address this issue and will be provided electronically upon request. The attachment provided with the customer letter identifies the updated sections of the new User Guide related to annual maintenance testing. This action has been closed-out on 02/02/2016.
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.
Notas adicionales en la data
Causa
Haag streit has identified a potential issue with the slide-in adaptor plug for the perkins mkiii tonometer charger. an incident was reported to haag-streit where the use of the adaptor tripped a customer’s circuit breaker. upon investigation it was found the adaptor contained an electrical fault. this electrical fault has the potential to cause arcing within the adaptor, which poses a potential fire hazard. the risk when using the adaptor is most apparent if the adaptor is used in an un-fused circuit. the risk of harm and damage can be reduced if the unit is plugged into a conforming power outlet with a circuit breaker.
Acción
Users are advised to isolate the affected Plug Adaptors from use. A DTA representative will contact users in regards to replacement of affected stock.