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