GE Healthcare MR superconducting magnets — Class II medical device recall Z-0613-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-02-16, distributed nationwide. The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the vent
| Recall number | Z-0613-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-12-23 |
| Classified | 2022-02-09 |
| Reported by FDA | 2022-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 17,228 devices |
Product
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Reason for recall
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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-0613-2022. 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.