SIGNA Premier magnetic resonance scanner — Class II medical device recall Z-1430-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-07-27, distributed nationwide. Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. A
| Recall number | Z-1430-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-07-21 |
| Reported by FDA | 2022-07-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CN, ES, FR, GB, HK, IN, IT, JP, KR, KW, NO, OM, SA, SE, SK, TH, TR |
| Quantity | 52 |
| UPC / GTIN / UDI-DI | 00195278010797, 00840682135269 |
| Model numbers | 5748519 |
Product
SIGNA Premier magnetic resonance scanner, model 5748519.
Reason for recall
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
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-1430-2022. 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.