PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

On October 2, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer/user in order to prevent risks for patients a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU) and the instructions below. b. If you experience inconsistent (not smooth) or no motorized longitudinal movement of the FlexArm stand and you receive (or have received) the error messages described in Section 1 of this Medical Device Correction letter, please report the issue to Philips. c. If the FlexArm s longitudinal motorized movement stops during a procedure, position the C-arm manually by using the handgrips and brake controls on both sides of the FlexArm stand or reposition the table in longitudinal position if the available distance is sufficient. d. As part of the preventative maintenance cycle Philips will clean the rails, friction wheel and bearings as indicated in the Preventive Maintenance Update attached in Appendix A. o Keep a copy of this Preventative Maintenance Manual Update with your current manual. o If you do not use Philips to perform the preventative maintenance on your system, provide a copy of the Preventive Maintenance Manual Update to your qualified and authorized service provider. e. Circulate this Urgent Medical Device Correction Letter to all users so that they are aware of the issue and follow the instructions above. Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. f. Complete and return the attached response (page 05) form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and actions required. Actions planned by Philips Image Guided Therapy Systems to correct the problem Philips will replace the existing longitudinal bearings on the affected Azurion 7M20 systems with FlexArm stand with re

• FDA enforcement recordOfficial FDA database entry for Z-0719-2026
• 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.