GE Healthcare — Class II medical device recall Z-0201-2019
Terminated recall by GE Medical Systems, LLC, reported 2018-10-31, distributed in AZ, CA, CO, DC, DE, FL, IL, IN…. GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used wit
| Recall number | Z-0201-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2015-12-07 |
| Classified | 2018-10-22 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2018-11-08 |
| Distributed | AZ, CA, CO, DC, DE, FL, IL, IN, MD, ME, MI, MN, MO, NC, NH, NY, OH, OK, OR, PA, PR, SD, TN, TX, VA, WI |
| Countries outside the US | AU, BR, CA, CH, CN, CZ, DE, EE, EG, ES, FR, GB, ID, IT, JP, KR, KW, MX, NL, NZ, PL, PT, RO, RU, SA, SE, TR, TW, ZA |
| Reason classes | device malfunction, software |
Product
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
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-0201-2019. 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.