Safety Alerts

Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its Spectral CT systems [Model number: 728333, 728340; Serial Number: 10014, 396002] [HKMD No.: 220236].

The manufacturer has identified the four potential issues that could affect the performance of CT system(s).

1. An interruption during the ‘get ready for scan’ stage of a scan may occur.
2. An interruption during the ‘get ready for scan’ stage of a scan may occur.
3. An interruption during the initiation of ‘surview scanning’ may occur. The error message is triggered after the following sequence:
   • The user adjusts the vertical motion of the couch.
   • The user then quickly selects “GO” to initialize the system.
   • The vertical brake is engaged and triggers the error message.
4. During ‘bad detector calibration’, the calibration may fail, and an error message may occur.

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

Posted on 24 Jun 2024