Z-0719-2026Class II

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

Name: Z-0719-2026 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-10-02
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-10-02 / Open, Classified / root cause: manufacturing process

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234 on 2025-10-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0719-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-02
Posted: 2025-11-26
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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;
Product codes and lots: Model Number: 722234;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0719-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0719-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code OWB

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)