GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-1546-2021)

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:

NM/CT 860 Nuclear Medicine / CT Scanners

Product Classification:

Class II

Date Initiated: February 7, 2021

Date Posted: May 19, 2021

Recall Number: Z-1546-2021

Event ID: 87811

Reason for Recall:

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

Status: Ongoing

Product Quantity: 242 in total (17 units US)

Code Information:

GTIN*00840682140751

Distribution Pattern:

Worldwide distribution - US Nationwide

Voluntary or Mandated:

FDA Mandated