GE Healthcare Discovery MR450 — Class II medical device recall Z-1533-2014
Terminated recall by GE Healthcare, LLC, reported 2014-05-07, distributed in DC, GU, ND, PR, RI, WY. GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egre
| Recall number | Z-1533-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-04-23 |
| Classified | 2014-05-01 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-01-21 |
| Distributed | DC, GU, ND, PR, RI, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, HK, HR, HU, ID, IE, IL, IN, IT, JP, KR, KW, KY, LB, MA, MX, NL, NO, NZ, OM, PL, QA, RO, RS, RU, SA, SE, SG, TH, TN, TW, UY, VE, ZA |
| Reason classes | device malfunction |
Product
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.
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-1533-2014. 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.