Safety Alerts

Medical device manufacturer, Philips Medical Systems Nederland B.V., has issued a medical device safety alert concerning its Philips Azurion 7 M20 FlexArm system with Maquet Magnus Table [Software version: 05.02.12] [HKMD No.: 200480 and 230373].

The manufacturer has become aware of two potential safety issues with the Azurion 7 M20 FlexArm system (“FlexArm”) with a Maquet Magnus Table with software version 05.02.12 (“Table”).

1. Connection Issue:
   • If, during a procedure, the detector is positioned at a distance of approximately four (4) cm from the patient, the connection between the FlexArm and the Table may be lost due to a software issue. When this occurs, the Table and the FlexArm-System will automatically reconnect after approximately 10 seconds, during which Table movement will be unavailable.
2. Date and Time Issue:
   • When the FlexArm system is (re)started, the FlexArm and Table may not connect due to a software issue. This occurs when the date/time format includes more than three (3) leading zeros (see examples below). The connection will be established automatically once one of the leading zeros changes to a “one (1)”.

Until the connection is established, the FlexArm system will be fully functional, but Table movement will not be available.

A loss of motorized Table movement due to the Date and Time Issue at start-up of the FlexArm could result in a delay of up to 10 minutes. A loss of motorized Table movement, and potentially FlexArm movement during a procedure could result in a delay in the procedure or termination of the procedure. The potential delay in treatment and/or termination of the procedure may result in adverse outcomes, including the possibility of death for some of the most critical patients.

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

Posted on 19 Dec 2023