GE Healthcare — Class II medical device recall Z-1305-2015
Terminated recall by GE Healthcare, reported 2015-04-01, distributed nationwide. GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not
| Recall number | Z-1305-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-03-09 |
| Classified | 2015-03-20 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, 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, IS, IT, JM, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NG, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00000000004428, 00082427010008, 00082427010046, 00082427010053, 00082427020038, 00082427020045, 00082427020052, 00082427030020, 00082427030068, 00082427030075, 00082427040012, 00082427040029, 00082427040043, 00082427040050, 00082427040067, 00082427040074, 00082427040081, 00082427040098, 00082427040104, 00082427040142, 00082427040159, 00082427050011, 00082427050028, 00082427060027, 00082427060034 and 107 more |
| NDC | 02003-0128-30, 02003-0818-17 |
| Model numbers | 00000000090M21, 000000000R1897, 000000000R7508, 00000000203M20, 00000000258M24, 00000000281M26, 00000000380M26, 00000000530M26, 00000000577M27, 00000000581M29, 00000000596M27, 00000000698M21, 00000000701M23, 00000000702M21, 00000000705M24, 00000000745M20, 00000000748M24, 00000000761M27, 00000000789M28, 00000000823M25, 00000000853M22, 00000000890M24, 00000000957M21, 00000000958M29, 00000000981M21 and 475 more |
Product
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems
Reason for recall
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
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-1305-2015. 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.