Events

Recall of Philips Brightview XCT

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 (USA).

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
    21085
  • Event Initiated Date
    2017-02-10
  • 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 intends to release a revision of the instruction for use with an amendment to the intended use. the amendment is the result of a mismatch of intended use between the ifu released globally & the 510 (k) regulatory submission in the us. the claims in the labelling describe additional functional capabilities of the system, which while not cleared in the us, remain accurate and supported by the manufacturer.
  • Action
    Instructions for use to be updated

Device

Philips Brightview XCT

Manufacturer

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