medical Class II Updated 2021-08-04

GE OEC Medical Systems, Inc recalls OEC Elite mobile C-arm - Product Usage: intended to provide

Recalled Product

OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.


Hazard / Issue

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All OEC Elite systems manufactured on or after January 2019
View official government recall

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