Events

Recall of Philips BrightView XCT Imaging System

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

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
    15353
  • Event Initiated Date
    2013-09-16
  • 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
    Philips received a report from the field that the fpd failed to remain securely latched in the stowed position., a system warning message appeared warning the user that the fpd was unlatched. by design, the unlatching of the fpd caused the system to activate the e-stop. in an attempt by the operator to clear the warning message while in the 0 degree position, the fpd released from the stowed position.
  • Action
    Product to be modified

Device

Philips BrightView XCT Imaging System

Manufacturer

Philips Radiation Oncology Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA