Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
FDA Recall #Z-0719-2026 — Class II — October 2, 2025
Product Description
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
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.
Recalling Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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;
Code Information
Model Number: 722234;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated