Events

Safety Alert for brightview xct

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips 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
    2013-09-09
  • Event Date Posted
    2013-09-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130909.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: philips brightview xct the therapeutic goods administration (tga), australia posted a medical device safety alert concerning brightview xct manufactured by philips healthcare (model numbers 882482 and 882454). philips received a report from the field that the flat panel detector (fpd) sensor reported to the operator that the panel was unlatched at the zero degree position during setup. the operator attempted to manually relatch the fpd as it remained in the zero degree position. in trying to restow the fpd, it fell from its stowed position and contacted the patient's leg and the technologist's arm. the manufacturer advises customer to keep the fpd in the deployed position until the implementation of the appropriate field safety correction. for details, please refer to tga website http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00944-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 9 september 2013.

Device

brightview xct
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips BrightView XCT
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH