Events

Safety Alert for Ingenuity Core

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips.

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
    2018-04-16
  • Event Date Posted
    2018-04-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180416.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 ingenuity core the therapeutic goods administration (tga), australia posted a medical device safety alert concerning philips ingenuity core [model number: 728321; serial number: 333175]. the manufacturer has identified systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that: prevents system access; or a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real time. according to the manufacturer, there have been no reports of patient harm as a result of this issue. the manufacturer will contact the users to arrange an appointment for a field service engineer to correct the software on any potentially impacted systems for details, please visit the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00312-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2018.

Device

Ingenuity Core
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Ingenuity Core
  • Manufacturer
    Philips

Manufacturer

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