GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1951-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Product Classification:

Class II

Date Initiated: January 19, 2019

Date Posted: July 24, 2019

Recall Number: Z-1951-2019

Event ID: 83254

Reason for Recall:

Additional low dose radiation exposure.

Status: Ongoing

Product Quantity: 857 (US = 195: OUS = 662)

Code Information:

Revolution CT

Distribution Pattern:

Worldwide - US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated