NM/CT 870 DR Nuclear Medicine / CT Scanners — Class II medical device recall Z-1547-2021
Ongoing recall by GE Healthcare, LLC, reported 2021-05-19, distributed nationwide. GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in C
| Recall number | Z-1547-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-02-07 |
| Classified | 2021-05-11 |
| Reported by FDA | 2021-05-19 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00840682140836 |
Product
NM/CT 870 DR 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1547-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.