Events

Safety Alert for brilliance 64 and ingenuity ct scanners

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
    2015-08-21
  • Event Date Posted
    2015-08-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150821_b.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 healthcare brilliance 64 and ingenuity ct scanners medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its brilliance 64 and ingenuity computed tomography (ct) scanners. the affected ct systems are brilliance 64, ingenuity ct, ingenuity core and ingenuity core128. only systems with the following versions are affected: 4.0.X.Xxxx- any version of 4.0 4.1.Y.Xxxx -only version up to and including 4.1.4. according to the manufacturer, some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan. the issue occurs only when the following three conditions are met: the plan employs dual-surview the plan requests either a sagittal or a coronal reconstruction the gantry is tilted there is a potential for undesired radiation to areas not intended to be scanned. the manufacturer is not recommending users to stop using the equipment. to eliminate the possibility of the defect from occurring, users are advised to eliminate any one of the three conditions mentioned above which is needed to trigger the behaviour. the manufacturer is developing a new version of software to eliminate the defect. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 august 2015.

Device

brilliance 64 and ingenuity ct scanners
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Healthcare Brilliance 64 and Ingenuity CT Scanners
  • Manufacturer
    Philips Healthcare

Manufacturer

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