FDA-Device2024-09-11Class II
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
927 systems
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2024Don't want to check this manually?
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