GE Healthcare MR Systems — Class II medical device recall Z-0983-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-04-27, distributed nationwide. During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for t
| Recall number | Z-0983-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-03-04 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, 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, 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, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 18,411 systems |
Product
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.
Reason for recall
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
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-0983-2022. 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.