FDA recall Z-1546-2021

GE Healthcare, LLC · Class II · device

Product

NM/CT 860 Nuclear Medicine / CT Scanners

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.

Distribution

Worldwide distribution - US Nationwide

Key facts

Status: Ongoing
Initiation date: 2021-02-07
Report date: 2021-05-19
Voluntary/Mandated: FDA Mandated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1546-2021