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Recall Observatory FDA recall evidence

Device product

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

Z-0719-2026

October 02, 2025

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 97719
Status
Ongoing
Classification
Class II
Quantity
172 units
Official record key
device-enforcement:Z-0719-2026

Official wording

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.

Code information: Model Number: 722234;

Distribution pattern: 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;

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.