Optima MR430s MRI Scanner — Class II medical device recall Z-1212-2013
Terminated recall by GE Healthcare, LLC, reported 2013-05-08, distributed in AL, CA, CO, FL, ID, IL, MA, NH…. Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
| Recall number | Z-1212-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-05-01 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2013-10-25 |
| Distributed | AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BR, CA, CH, CL, DE, DK, EG, ES, FI, GB, IN, IT, JP, KR, MY, NL, NO, PE, PL, RU, SG, UA, ZA |
| Quantity | 81 |
| Reason classes | packaging |
Product
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Reason for recall
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
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-1212-2013. 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.