Events

Safety Alert for Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera

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

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
    2013-04-18
  • Event Date Posted
    2013-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130418b.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 healthcare quasar nuclear medicine system, hawkeye option and hawkeye 4 option for dual-head variable angle gamma camera the united states food and drug administration (fda) has issued a medical device safety alert concerning quasar nuclear medicine system, hawkeye option and hawkeye 4 option for dual-head variable angle gamma camera manufactured by ge healthcare, llc. all infinia systems and all configurations are affected. according to the safety alert, accelerated fatigue of the lateral axis motion subsystem of the infinia computed emission tomography system could result in mechanical failure causing the detector to slide, which may impact patient and operators. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm? action=detail&id=64398&w=04172013&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 april 2013.

Device

Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle ...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare