PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12

Possibility of the patient falling from the table related to the mattress used on the patient table.

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

On January 14, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users " 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 on the use of the mattress included in Appendix B. These instructions include information for the transfer of the patient and the correct use and positioning of the mattress. 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). 5. Actions planned by Philips Image Guided Therapy Systems to correct the problem Philips is informing customers of this issue through this Urgent Medical Device Correction. Additionally, 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. This Urgent Medical Device Correction letter has been reported to the appropriate Regulatory Agencies.

• FDA enforcement recordOfficial FDA database entry for Z-1153-2025
• FDA 510(k) clearance · K163715The device's official FDA premarket clearance record
• FDA 510(k) clearance · K172822The device's official FDA premarket clearance record
• 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.