Recall – CT System software may leave image artifacts

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

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.