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.
Notes supplémentaires dans les données
Cause
The tga received an incident report and examined a kidwalk mobility aid, which had failed at the base of the mast. tga’s investigation recommended to reinforce and update three important points in the owner’s manual (instructions for use) for the kidwalk with aluminium mast supplied prior to december 2010:· considerations on re-issue of the kidwalk.· regular inspection and annual service of the kidwalk · the intended purpose of the kidwalk.
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.
Notes supplémentaires dans les données
Cause
Ortho-clinical diagnostics, inc. (ocd) recently received complaints of elevated results using heparin plasma samples for vitros chemistry products dgxn slides. as a result of their investigation into these complaints, heparin plasma is being removed as a recommended specimen type for vitros dgxn slides.
Action
Laboratories are being advised to immediately discontinue using heparin plasma for VITROS DGXN Slides and to discuss previously reported results with the Laboratory Medical Director to determine appropriate course of action. Update your laboratory's Instructions for Use (IFU) Manual with the revised instructions that are provided with the recall notice.
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.
Notes supplémentaires dans les données
Cause
A software anomaly has been identified with the eclipse treatment planning system where changing the prescription in a calculated vmat or rapidarc plan may lead to monitor units which do not reflect the new prescription. if the dose prescription of a vmat or rapidarc plan is changed after the initial dose volume optimisation, the monitor units and dose distribution may not reflect the intended prescription.
Action
Varian is recommending users to implement work around instructions until a software fix is developed and implemented.
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.
Notes supplémentaires dans les données
Cause
The manufacturer received a report that the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube.
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.
Notes supplémentaires dans les données
Cause
The ‘cold soak disinfection’ section of the instructions for use requires the inclusion of a rinse step which is necessary post-disinfection with gluteraldehyde / cidex.
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.
Notes supplémentaires dans les données
Cause
This action is occurring worldwide because of a high incidence of wear, known as fretting and corrosion, at the join between the femoral stem and the neck component. fretting and corrosion can result in metal debris in and around the hip joint. if this occurs, patients may experience inflammation, adverse local tissue reactions (altrs), hypersensitivity/allergic reactions and osteolysis (bone loss).
Action
The ABGII Modular Femoral Stem and Modular Neck has been cancelled from the Australian Register of Therapeutic Goods (ARTG). Stryker Australia Pty Ltd has contacted orthopaedic surgeons who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. For more details, please see https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system and https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system-update .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
These batches may not function as designed. the manufacturer has advised that 1 in 10 could possible have a vacuum leak.
Action
Quarantine and return affected stock to Endeavour Medical and Surgical Supplies
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.
Notes supplémentaires dans les données
Cause
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.
Action
FAS Therapeutic Equipment is providing customers with amended instructions for use advising that the Ultima Bath Chair should not be adjusted while occupied.