Events

Recall of CombiDiagnost R90

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems DMC GmbH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22314
  • Event Initiated Date
    2017-11-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    The manufacturer has become aware that in some combidiagnost deliveries the tube adapter-plate green/yellow protective earthing wire was removed, during gcf tubes assembly, spacers with different thickness are used to position pre-loc ring in respect to focal spot in specified distance., there is a potential of an electrical shock if following factors occurs:, 1. an electrical failure leads to an electrical potential on the adapter plate, 2. the earth resistance based on mechanical connection is beyond limit, 3. person removes the tube cover. (not allowed for the customer), 4. person touches the live wired part during exposure/fluoroscopy.
  • Action
    Product to be modified

Device

CombiDiagnost R90

Manufacturer

Philips Medical Systems DMC GmbH
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA