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

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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;
Recall initiated
2025-10-02
Code info
Model Number: 722234;
Product quantity
172 units
Voluntary mandated
Voluntary: Firm initiated
City
Best
State
N/A
Country
Netherlands
Event id
97719
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