Company: GE Healthcare, LLC
Date of Enforcement Report: 11/4/2020
Class II

PRODUCT

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 – Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Recall Number: Z-0306-2021

REASON

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 9/21/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

64 devices

DISTRIBUTION

U.S. Nationwide and International