This correction applies to all GE Healthcare MRI systems with… — Class I medical device recall Z-1035-2015
Terminated recall by GE Healthcare, reported 2015-02-25, distributed nationwide. At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU coul
| Recall number | Z-1035-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-01-07 |
| Classified | 2015-02-18 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-09-10 |
| 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, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| UPC / GTIN / UDI-DI | 00000000004428, 00082427010008, 00414300000460, 08302706198282, 83027000020213, 83027000143110, 83027001018110, 83027001106411, 83027002000329, 83027002001708, 83027002100418, 83027062894111, 83027102000908, 83027200005713, 83027202101819, 83027208277419, 83027209918410, 83027240003113, 83027240013211, 83027241593910, 83027288790310, 83027600019013, 83027601746512, 83027802101547, 83027820038511 and 5 more |
| NDC | 02003-0128-30, 02003-0818-17 |
| Model numbers | 00000272435MR9, 205750MR04, 205822MR1, 212140MR2, 215728HD, 219326MR, 269945MR, 307672MR, 317338MR4, 352401MR, 401348MR1, 402778OWMR1, 406863WMR, 417256MR2, 513247MR, 513894MR, 518782LMR2, 520202MR, 520381MR1, 541608MR, 561650MR2, 561694MR3, 601815MR1, 606439HDMR, 609597MR1 and 17 more |
Product
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
Reason for recall
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
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-1035-2015. 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.