FDA recall Z-2953-2024

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

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.

Key facts

Status
Ongoing
Initiation date
2024-08-06
Report date
2024-09-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2024