Allura R8.2.x Systems (Philips) – Imaging Functionality Loss (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

Recommended Action

Per FDA guidance

Philips notified consignees on 06/30/2025 via letter. Consignees were informed what the issue was and under what circumstances it can occur and how to identify affected units. Consignees were instructed to notify all relevant personnel, avoid rapidly pressing and releasing the footswitch pedals, if the X-ray functionality is not available during the issues described in the notification, follow specific outlined steps, and notify customers if the units have been transferred or further distributed. Additionally, consignees were requested to maintain the notification with the system until the software update is complete and to complete and return the response form.