Company: GE Medical Systems, LLC.
Date of Enforcement Report 12/16/2015
Class lI:

PRODUCT

GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
Recall Number Z-0401-2016

REASON
GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.

RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI. on 10/23/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
125 (US = 37; OUS = 88)

DISTRIBUTION
Nationwide and Internationally

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