SIGNA Premier systems — Class II medical device recall Z-1767-2026
Ongoing recall by GE Healthcare LLC, reported 2026-04-08, distributed nationwide. Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may
| Recall number | Z-1767-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare LLC, Florence, SC, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-04-02 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CN, DE, ES, FR, GB, GR, KR, NO, PT, SE, VN |
| Quantity | 41 |
| UPC / GTIN / UDI-DI | 00195278010797, 00840682135269 |
Product
SIGNA Premier systems
Reason for recall
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
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-1767-2026. 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.