Medical Device Recall: 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. · August 6, 2024
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.
Distribution
Worldwide - US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
927 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2953-2024
Status: ongoing
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