Events

Safety Alert for brilliance ct series , ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx8000 dual v. exp

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
    2014-04-15
  • Event Date Posted
    2014-04-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140415.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 brilliance ct series (6, 10, 16, 16 power, 40, 64, big bore, ict, ict sp), ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx8000 dual v. exp medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its brilliance ct series (6, 10, 16, 16 power, 40, 64, big bore, ict, ict sp), ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx8000 dual v. exp. thethe manufacturer has found that if the service latch is not properly secured during servicing of the device, the table top’s subframe will become free floating causing unintended, horizontal motion. the manufacturer has identified the following potential hazards: for the patient: there is a potential for disconnection or movement of invasive medical devices such as i.V.’s, tracheostomies, and surgical drains. for the operator/technician: there is a potential for pinch point on the subframe and also a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward. the manufacturer advises users to contact their field service engineers immediately if they experience a horizontal, free-floating couch motion. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 april 2014.

Device

brilliance ct series , ingenuity ct, ingenuity core, ingenuity core128, ingenuity flex, and mx800...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and MX8000 Dual v. EXP
  • Manufacturer
    Philips Healthcare

Manufacturer

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