Events

Safety Alert for XR 6000 systems

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
    2016-10-31
  • Event Date Posted
    2016-10-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161031.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 xr 6000 systems the health sciences authority (hsa) of the singapore has posted a medical device safety alert concerning xr 6000 systems, manufactured by ge healthcare. the manufacturer has recently become aware of a potential safety issue with the horizontal tube arm of the system used on xr 6000 systems. there has been a reported incident of a horizontal tube arm falling from the system. a fall of a tube arm suspending the collimator and tube apparatus could result in a serious injury or death to a patient or operator. a minor injury has been reported as a result of this issue. the manufacturer will correct the affected systems. the manufacturer recommends users not to use the xr 6000 system until they are corrected. for details, please refer to the hsa’s website: http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2016/september.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2016.

Device

XR 6000 systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare XR 6000 systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare