GE Healthcare, LLC recalls Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whol

Recalled November 4, 2020 · FDA recall Z-0306-2021 · GE Healthcare

Hazard

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

Units

64 devices

Sold at

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Description

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

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.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →