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
Specific lots of sharpoint iq geometry slit knives potentially have bent tips.
Acción
Quarantine and return affected stock to IQ 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.
Notas adicionales en la data
Causa
It has been reported that in certain cases screws securing the electronic circuit board inside the product became loose and fell out, potentially damaging the internal electronic circuit board, resulting in malfunctions including a loss of power in some cases and possible image failures.This recall action was not notified to the tga before it was initiated by canon australia.
Acción
Canon Australia is initiating a recall for product correction to replace all affected product sensor units.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Covidien has received one report that links the duet trs tissue reinforcement material to a post operative injury after abdominal surgery.
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
Ev3 has identified a regulatory compliance issue with the protege everflex self-expanding peripheral stent system range of products. the majority of these products were included in the australian register of therapeutic goods under artg 151132. however, the additional sizes with the smallest diameter stent of 5mm and the 6-8mm stents of greatest length of 200mm were inadvertently released prior to the tga's review and approval for inclusion under artg 151132.
Acción
EV3 Australia is asking hospitals to quarantine the affected stent system in a controlled area. Ev3 is advising clinicians that availability of the affected stent system is limited to patients eligible under the Special Access Scheme. Alternatively, individual clinicians can apply to the TGA to become an Authorised Prescriber.
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 healthcare diagnostics has determined that a small amount of residual cleaning solution may remain in the system fluidic lines following the monthly cleaning procedure (mcp) and the daily cleaning procedure (dcp).
Acción
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.
Notas adicionales en la data
Causa
There is a potential failure of the integrated module housing; causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
Acción
Medtel is providing work around instructions to users to mitigate the issue until a permanent fix can be 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.
Notas adicionales en la data
Causa
There is a labelling discrepancy pertaining to certain configurations of the mahurkar acute dual lumen catheter. during a review of the product labelling, it was discovered that the devices are labelled as not containing the phthalate bis (2-ethylhexyl) phthalate (dehp), when in fact they contain small amounts of dehp.
Acción
Update labelling to include phthalate Bis (2-ethylhexyl) phthalate(DEHP) symbol.
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 material fault has been identified affecting contact discs in specific lots. this material fault results in the contact discs becoming loose after autoclaving. this issue may result in contact problems with the handles causing them to be on constantly, to flicker or not to function.
Acción
Identify and quarantine affected products. Return the quarantined stock to LMA PacMed for replacement 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
Dentsply australia pty ltd has been advised that a limited number of water filters used on cavitron scaler and air polishing units overseas have developed leaks.
Acción
Dentsply are providing replacement filters for all affected units.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker orthopaedics has received reports from the field indicating that certain lots of 6.5mm cancellous bone screws are potentially associated with a product label mix. the packaging label associated with a 35mm screw may contain a 25mm screw.
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 determined that the previ isola system pipettor may fail to dispense a sample due to the pipettor becoming clogged. the resulting failure to dispense may be caused by all specimen types verified for use with the previ isola system.
Acción
Update to Instructions for Use (IFU) and 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 identified that when the t-handle on the hraim intubation hoop is tightened on some units, it may stop in a vertical position that prevents the crwprecise (crw precision stereotactic frame) and crwasl (crw arc system) from being properly seated on the head ring.
Acción
Integra is providing work around instructions to mitigate the issue and will be contacting all users to replace affected screws.
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 patient support may move in an unintended manner if the foot switch cover impinges on the foot switch. damage to the foot switch cover can occur when the couch is lowered and the patient support cover presses down on the foot switch cover and bends it. this can lead to the foot switch cover being deformed in a manner that causes the foot switch cover to engage the unload foot switch. this can lead to unintended movement of the patient support, such as intermittent operation of up and down movement or continued movement when the pedal is released.
Acción
Philips Healthcare is providing work around instructions and is planning to replace the sheet metal multi function footswitch.
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 device labelling identifies the affected parts as having a ten year shelf life, however the packaging configuration that was used qualifies it as a five year shelf life.This recall action was not notified to the tga before it was initiated by exactech australia.
Acción
Cease sale, use and further distibution of the affected products and return the stock to Exactech Australia.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
An addendum of the operating manual has been released to provide more detailed description about the emergency release of the compression unit in case of system error or a power failure.
Acción
The sponsor is providing an update to 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.
Notas adicionales en la data
Causa
An onboard stability issue is resulting in an out of specification calibration interval potentially giving rise to false positive results.
Acción
Siemens is providing work around instructions for users to follow. This action has been closed-out on 16/02/2017.
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 pty ltd withdrew the durom acetabular component from the australian market, with effect from 30th june 2011, due to a decline in sales. a hazard alert is being issued in response to the tga’s proposal to cancel the inclusion of the durom acetabular component from the artg based on the devices cumulative revision rate of 9.6% at 7 years in resurfacing applications and 6.8% at 5 years for total conventional hip replacements as reported in the 2011 national joint replacement registry (njrr) report.
Acción
Zimmer is advising implanting/treating surgeons on how to manage patients implanted with Durom Acetabular Components. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-dac-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.
Notas adicionales en la data
Causa
In rare cases, product information on the patient label, with respect to ref number/lot number, might not coincide with the corresponding information on the product label.
Acción
Zimmer have provided work around instructions for users to implement.
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 units of the reagents in these lots may contain microbial contamination that could impact assay procedure and/or performance.
Acción
Laboratories to inspect stock and remove from use any units from affected lot numbers. Previous results issued from these lots should be reviewed.
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
Bausch & lomb recently determined that posterior fluidics modules (pfms) installed in the stellaris pc vision enhancement systems listed may need to be recalibrated. these modules, which regulated the performance of the vitrectomy probe, may exhibit behaviour that could result in less efficient aspiration.
Acción
Bausch & Lomb is providing work around instructions to mitigate the issue and will be replacing the posterior fluidics module to correct the problem.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Baxter has received complaints for the buretrol ball-valve products with reports of air travelling below the ball-valve in the drip chamber and into the tubing. the ball-valve component is designed to prohibit the flow of air from the burette into the tubing as the burette is emptied. upon further investigation baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Acción
Baxter is recalling all affected sets and replacing it with unaffected product codes.
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
When the clock on the eclipse client workstation is running behind the clock on the database/system server, it is possible that a change to the assigned hu value for a structure dose not invalidate the density image stored in the cache, and for the subsequent dose and monitor unit calculation to be based on the outdated hu assignment. the resultants mus may be higher or lower than expected. treatment of the patient using these values can lead to under or overdosing.
Acción
Varian is providing users with work around instructions and will be providing a technical correction to permanently correct 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.
Notas adicionales en la data
Causa
The manufacturer has become aware that the spectra optia system's return line air detector (rlad) can potentially fail as a result in a non-continuable alarm condition. if air has been falsely detected due to a defective rlad during a procedure, a continuous "air detected in return line" alarm will occur and will not allow the procedure to continue. if the rlad experiences a defect during prime, the system will generate a "return line air detector failed fluid check" alarm and will not allow the procedure to be performed until serviced.
Acción
Terumo BCT 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.
Notas adicionales en la data
Causa
The manufacturer has identified that lot to lot variability has resulted in the relative specificity not meeting the product instructions for use (ifu) claims.
Acción
Update to IFU claims. This action has been closed-out on 28/04/2016.
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
Due to an incident involving the back rest on an ultima bath chair, the manufacturer has updated the instructions for use (ifu) on adjusting the back rest and pre-use safety checks.
Acción
FAS Therapeutic Equipment is providing customers with amended instructions for use advising that the Ultima Bath Chair should not be adjusted while occupied.