FDA Device recall Z-1545-2021
NM/CT 850 Nuclear Medicine / CT Scanners
- FDA Device
- Class II
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of NM/CT 850 Nuclear Medicine / CT Scanners by Ge Healthcare, citing 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 radi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1545-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-07 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
NM/CT 850 Nuclear Medicine / CT Scanners
Reason
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.
Identifiers
| code_info | GTIN*00840682140775 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1545-2021%22
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