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

Recall number

Z-0719-2026

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

Status

Open, Classified

Initiated

2025-10-02

Posted

2025-11-26

Terminated

not on file

Reason

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.

Root cause

Equipment maintenance

Action

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

Quantity

172 units

Distribution

Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY, OH, OK, PA, RI, TX, UT, VA, WA, WI, WV, WY; International: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Netherlands, Norway, Philippines, Poland, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Vietnam;

Lot, serial or model codes

Model Number: 722234;

510(k) numbers

["K200917"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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