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
    39341
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-07
  • 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
    Several software issues which will be corrected with the release of a new software version. 1-following a cardiac scan and when using smartstep to setup the camera for a relative 180 procedure it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed. this affects only the brightview xtc systems. 2-during a patient spect lung acquisition the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degee position. however in the middle of a clinical scan acquisition the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degrees to the 240 degrees may take approximately 7 seconds. 3-at the completion of a thyroid procedure the operator executed the pinhole pre-programmed motion (ppm) and noticed a change in the sequence of motions between the imaging pallet and the detector radius. the system moved the patient pallet from the gantry before the detector installed with the pinhole collimator was moved out of the path of the patient. this sequence of motions differed from the previous software release. this affects systems with software version 1.2.3/2.5.3.

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: 2170-3000A (Lot serial: ALL); Model Catalog: 453560749161 (Lot serial: ALL); Model Catalog: 453560462131 (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