Safety Alerts

The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Philips Medical Systems DMC GmbH (Philips North America) ProxiDiagnost N90 [Ref: (1)706100 (2)706110] and ProxiDiagnost upgrade [Ref: 706150] [HKMD number: 210062].

According to the FDA, there are two issues:

• Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient's radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image.
• Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)

For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93773

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

Posted on 15 Feb 2024