GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-2004-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Revolution CT

Product Classification:

Class II

Date Initiated: March 19, 2021

Date Posted: July 14, 2021

Recall Number: Z-2004-2021

Event ID: 88150

Reason for Recall:

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

Status: Completed

Product Quantity: 197 (US = 40; OUS = 157)

Code Information:

5590000 5590000-6 5590000-2

Distribution Pattern:

Worldwide distribution - US Nationwide

Voluntary or Mandated:

FDA Mandated