Optima MR450w — Class II medical device recall Z-0935-2013
Terminated recall by GE Healthcare, LLC, reported 2013-03-20, distributed in GA, PR, RI. An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrec
| Recall number | Z-0935-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-05-10 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2016-06-30 |
| Distributed | GA, PR, RI |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, RO, RS, SA, SE, SG, SK, TH, TN, TR, TW, UY, VE, ZA |
| Serial numbers | 0000, 000000000R6708, 000000008393Y1, 00000002143YR6, 00000004672YR2, 00000004773YR8, 00000004984YR1, 00000005065YR8, 00000005067YR4, 00000005068YR2, 00000005069YR0, 00000005072YR4, 00000005073YR2, 00000005074YR0, 00000005076YR5, 00000005077YR3, 00000005078YR1, 00000005079YR9, 00000005080YR7, 00000005081YR5, 00000005082YR3, 00000005084YR9, 00000005232YR4, 00000005233YR2, 00000005525YR1 and 475 more |
Product
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
Reason for recall
An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
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-0935-2013. 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.