Events

Recall of 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
    21124
  • Event Initiated Date
    2017-02-21
  • 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 of a potential problem with brightview xct, with software issues in 2.5.5 and earlier., issue 1 - motion controller emit the warning message, occasionally, the system may stop and you may receive a "xct scan did not complete successfully"., issue 2 - door interlock switch with x ray perform, system was unable to perform an x-ray scan, after the system displays a "xct door interlock error., issue 3 - detector contacts head holder when performing patient unload, when performing a preprogrammed motion (ppm) to unload the patient, the detector will contact the head holder under the following circumstances:, - head holder installed, - rel-180 detector orientation, - gantry rotate angle between 45° and 55°, issue 4 - jetstream freezes during gated planar scan, when acquiring a gated planar scan (muga - multi gated acquisition) on a patient with an irregular heartbeat, you may encounter a situation where the acquisition station locks at 100% complete.
  • Action
    Software to be upgraded

Device

Brightview XCT

Manufacturer

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