SIGNA Architect AIR — Class II medical device recall Z-2131-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-07-30, distributed nationwide. GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this l
| Recall number | Z-2131-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-05-23 |
| Classified | 2025-07-18 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN |
| UPC / GTIN / UDI-DI | 00195278283481 |
Product
SIGNA Architect AIR
Reason for recall
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
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-2131-2025. 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.