Events

Recall of SYST BRIGHTVIEW X WITH CRYSTAL 3/8"(UPGRADEABLE VERSON)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    73927
  • Event Risk Class
    II
  • Event Initiated Date
    2013-12-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware of several software issues which will be corrected with the release of a new software version. problem 1: when positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly by an operator causing an inappropriate rotation orbit calculation for the patient being imaged. when the acquisition was started and the detectors began to move into position the incorrect calculation resulted in the detectors coming in contact with the patient. problem 2: on separate occasions as the gantry system was moving to a relative 90 scan position of the detectors a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator. problem 3: while a user was manually positioning the patient for their exam and translating the pallet into the gantry bore the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher. this problem can only occur on the brightview x or the brightview xct system.

Device

SYST BRIGHTVIEW X WITH CRYSTAL 3/8"(UPGRADEABLE VERSON)
  • Model / Serial
    Model Catalog: 453560829241 (Lot serial: ALL); Model Catalog: 2170-3002A (Lot serial: ALL); Model Catalog: 453560462131 (Lot serial: ALL); Model Catalog: 453560749161 (Lot serial: ALL); Model Catalog: 2170-3000A (Lot serial: ALL)
  • Product Description
    SYST BRIGHTVIEW X WITH CRYSTAL 3/8" (UPGRADEABLE VERSION)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC