Medical device manufacturer, Philips Medical Systems Nederland B.V. has issued a medical device safety alert concerning its Azurion System R1.x [Product Name: Azurion 3M12, Azurion 3M15, Azurion 7B12, Azurion 7B20, Azurion 7M12, Azurion 7M20; Model Number: 722063, 722064, 722067, 722068, 722078, 722079] [HKMD No.: 200480].
Philips has identified two issues in software version R1.x of the Philips Azurion system that may affect:
- Management of the system Log Trace Files:
The mechanism that is present in the system to manage the number and size of the system Log Trace Files does not function properly, as a result of which the Log Trace Files related to remote connection logging may occupy the full hard disk capacity of the Philips Azurion R1.x system. When the full disk capacity is reached, imaging (X-ray) functionality will cease to be available without an advance warning to the user. A restart of the system will not resolve the issue.
- Time to Perform a Cold Restart:
A cold restart of the Philips Azurion R1.x system may take up to 6 minutes as stated in the Instructions for Use of the system (Section 4.2). This time includes the time required for the system to shut down and the system to start up. However, there are instances where the shutdown of the system may be prolonged (with up to 4 minutes) resulting in the cold restart taking longer (up to 10 minutes in total).
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Jul 2024