Events

Safety Alert for Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GE Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-10-10
  • Event Date Posted
    2014-10-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141010.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ge millenium vg variable geometry dual detector camera-hawkeye, hawkeye 4, infinia dual detector gamma camera, discovery nm/ct 670 and nm 630 system health canada has issued a medical device safety alert concerning millenium vg variable geometry dual detector camera-hawkeye, hawkeye 4, infinia dual detector gamma camera, discovery nm/ct 670 and nm 630 system, manufactured by ge medical systems. according to the safety alert, the manufacturer performed a field action on ge healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. as part of this field action, the manufacturer updated the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners. for details, please visit the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/41685r-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2014.

Device

Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gam...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System
  • Manufacturer
    GE Medical Systems

Manufacturer

GE Medical Systems