medical Class II Updated 2021-08-04

GE OEC Medical Systems, Inc recalls OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System,

Recalled Product

OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations 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 3D Systems
View official government recall

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