Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

Philips Medical notified consignees on about 04/28/2026 via certified mailed letter titled "URGENT Medical Device Correction." Consignees were made aware of the issue and instructed to circulate the notification to all users of the system for awareness, that affected systems may continue to be used in accordance with their Instructions for Use (IFU), if the required position cannot be achieved using the Float Tabletop control for table movement, use alternative system movements (e.g., stand movement) where clinically feasible to adjust the relative position between the system and the patient, and avoid contact with sharp edges in the event that the Float Tabletop control is damaged. Consignees were also instructed to maintain the notification letter with the documentation of the system until Philips corrects the system, ensure the notification is located where it can be viewed, notify customers if system has been transferred, and complete and return the provided Response Form. Philips will install an auxiliary pan handle on all affected systems. A Philips representative will contact consignees to schedule the implementation of this correction. Philips expects to begin implementation of the correction by July 2026.