Safety Alerts

Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning the following Ingenuity CT and Brilliance CT 64 with software version 4.1.7 [Product code: 728321, 728323, 728326, 728327, 728324, 728325, 728231, 728232] [HKMD No.: 200454].

The manufacturer has identified two software issues affecting the performance of Ingenuity CT and Brilliance CT 64 systems with software version 4.1.7:

• Issue 1: Ingenuity CT 4.1.7 systems cannot be registered to the Remote Service Network
  • These systems cannot be connected to the Philips Remote Service Network, resulting in no access to the remote services such as software distribution or remote desktop connection abilities.
• Issue 2: Customer service intellectual property tool cyber security vulnerability
  • This issue impacts both Ingenuity CT and Brilliance CT 64 systems with version 4.1.7. If an unauthorized user utilizes counterfeit service tool security certificates; they may gain access to patient data, the service manual, and restricted service functions of CT devices.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 Nov 2023