Events

Safety Alert for brilliance ct 64, ingenuity core and ingenuity core128 systems

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
    2013-05-03
  • Event Date Posted
    2013-05-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130503.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 64, ingenuity core and ingenuity core128 systems medical device manufacturer, philips healthcare issued a medical device safety alert concerning all brilliance ct 64, ingenuity core and ingenuity core128 systems using software versions 2.6.1 or 3.5.4. philips healthcare received reports from the field that certain brilliance ct 64, ingenuity core and ingenuity core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. philips healthcare states that there are no proactive actions for the user. clinical judgment should be used by the customer or user to determine if the images contained in the dataset without artifacts contain enough information to make a diagnosis. if these images are sufficient, no further action is required. if the images are not sufficient, a rescan of the patient is required. philips healthcare is implementing software update versions 2.6.2 or 3.5.5 to correct the above-described issue. according to the local supplier, philips electronics hong kong ltd, 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 3 may 2013.

Device

brilliance ct 64, ingenuity core and ingenuity core128 systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Brilliance CT 64, Ingenuity Core and Ingenuity Core128 systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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