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
Elekta digital linear accelerator gantry base wheel bolts have been found to become loose and fail in some instances.
Acción
Elekta is informing customers that all gantry base wheel bolts should be checked and they should be replaced if found to be showing signs of fatigue.
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 reports related to a generator malfunction where the haloflex energy generator fails to enter “standby mode” when initially powered-on. the generator became stuck in the self-test mode upon initial power-on, did not enter standby mode, and therefore could not be used for patient care.
Acción
The customer letter provides temporary work around instructions. Covidien is developing a software revision, which will be available by the end of August 2012 that will prevent the malfunction from recurring.
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 spine has become aware that instruments of the affected lot may fracture at the hex tip of the torque wrench during final tightening.
Acción
Review the Xia 3 instrument trays for the affected wrenches. All affected wrenches must be removed and quarantined until collected or returned.
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 affected lot of cavitec may set slower than indicated in the directions for use.
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 has found that affected affinity four birthing beds, manufactured prior to 21 march 2012, may experience problems with the brakes. this may result in unwanted bed movement.
Acción
Providing work around instructions and correcting with enhanced brake system. This action has been closed-out on 11/02/2016.
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
Abbott vascular has discovered that some percutaneous transluminal angioplasty (pta) catheters may exhibit difficulty inflating and/or deflating.
Acción
Immediately remove and quarantine all inventory of affected part numbers so that they will not be used. Abbott Vascular will replace affected units with similar product, pending availability
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
Packages labelled as short-handled cutters (part number 803-0500) actually contained long handle cutters (part number 803-0501).
Acción
Ormco is asking customers to return the affected lots 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 received complaints of inaccurate results after calibration of hb1c (df105a). accuracy shifts of up to 27%, both high and low, have been reported on qc and patient samples. the shift observed with qc material is consistent with the direction and magnitude of the shift observed with patient samples.
Acción
End user to use updated scaler values for calibration of all affected lots.
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 product registration with tga is not yet complete and this product has been withdrawn pending the tga registration approval.
Acción
Quarantine and return affected products to NeilMed Pharmaceuticals
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 is notifying customers of an anomaly identified with the clinac, trilogy, novalis tx and unique jaw carriers. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under-dose of the intended target volume.
Acción
Onsite inspection and replacement of jaw carriers. 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
There have been isolated reports of postoperative fever and inflammatory reactions (in the absence of bacterial infection) with use of actifuse abx in paediatric patients undergoing surgical removal of large juvenile bone cysts. the reported side effects had no negative impact on therapeutic outcome or function of the actifuse product. the instructions for use will be updated to include the reported problems as precautionary statement.
Acción
Updated Instructions for Use (IFU) is being provided to all users of the affected devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
During the manufacturing process, the sealed edge may not have been uniformly formed and pleats or creases may have been formed which could have the potential to compromise the barrier integrity of the pouch.
Acción
Identify and quarantine affected products. Return the quarantined stock to Device Technologies for replacement stock 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
Potential for packaging particulate matter to reside on the product.
Acción
Quarantine and return recalled lots to Applied 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
There is a possibility of gradual downward movement of the overhead tube crane in the event of a power loss.
Acción
Adjustment of crane and fitting of a clamp to the pulley to prevent loss of tension
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
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
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.