FDA-Device2025-12-03Class II
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Sold states
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;
Affected count
172 units
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2026Don't want to check this manually?
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