PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12 System Code: (1) 722063 (2) 722221

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

Azurion 3 M12 System Code: (1) 722063 (2) 722221

Philips issued URGENT Medical Device Correction Letter via Certified Mail (USPS) on 1/13/25. Letter states reason for recall, health risk and action to take: " Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. " Follow the additional instructions when positioning the patient table included in Appendix B. These instructions include information of potential finger entrapment areas when moving the table. The information of this Appendix is being included in an Addendum to the Instructions for Use. Additionally, Philips is creating a Quick Reference Card. The Addendum and the Quick Reference Card will be available as from end of March 2025. Please refer to Appendix C on how to download the Addendum to the Instructions for Use and the Quick Reference Card. " In case that the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through the email account: IGT_Recalls@philips.com " Please complete and return the Response form attached to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter and understanding of the issue and required actions to be taken. " Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative (1- 800-722-9377). Actions planned by Philips IGT-S to correct the problem Philips is releasing an addendum to the instructions for use and a Quick Reference Card that will be available for customers at the end of March 2025. Philips is working on the design of additional brackets for the AD7 tables, and a new redesigned table cover for AD7X tables (ref. FCOs: FCO72200516, FCO72200552, FCO72200553, FCO72200554, FCO72200555, FCO72200556). Philips will contact you to schedule a visit once the ne

• FDA enforcement recordOfficial FDA database entry for Z-1087-2025
• FDA 510(k) clearance · K200917The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.