Events

Recall of MILLENNIUM VG VARIABLE GEOMETRY DUAL DETECTOR CAMERA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    75668
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-07
  • 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
    Ge healthcare has recently become aware of a potential safety issue related to unintended radial detector motion which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system for a whole body scan in which the detector moved to the home position and then slowly started drifting inward toward the patient.

Device

MILLENNIUM VG VARIABLE GEOMETRY DUAL DETECTOR CAMERA
  • Model / Serial
    Model Catalog: H3000YA (Lot serial: N/A); Model Catalog: NIL (Lot serial: N/A); Model Catalog: H3000WW (Lot serial: N/A); Model Catalog: H3000WT (Lot serial: N/A); Model Catalog: H3000WC/WD (Lot serial: N/A); Model Catalog: H3000YM (Lot serial: N/A); Model Catalog: H3000WZ (Lot serial: N/A); Model Catalog: H3000YS (Lot serial: N/A)
  • Product Description
    Millennium VG Variable Gemetry Dual Detector Cam
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)