MAGNETOM Skyra fit — Class I medical device recall Z-2661-2025
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2025-10-08, distributed nationwide. There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the e
| Recall number | Z-2661-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-08-28 |
| Classified | 2025-09-30 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, VN, ZA |
| Quantity | 56 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04056869006680, 04056869006710 |
| Serial numbers | 170001, 170002, 170004, 170007, 170009, 170010, 170011, 170016, 170017, 170018, 170019, 170023, 170030, 170036, 170039, 170041, 170043, 170044, 170046, 170047, 170048, 170049, 170050, 170053, 170054 and 29 more |
| Model numbers | 10849580 |
Product
MAGNETOM Skyra fit. Model Number: 10849580.
Reason for recall
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
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-2661-2025. 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.