GE Healthcare — Class II medical device recall Z-2131-2016
Terminated recall by GE Healthcare, LLC, reported 2016-07-13, distributed in AK, AZ, CA, CT, DC, FL, GA, GU…. GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Disco
| Recall number | Z-2131-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-06-08 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2018-10-04 |
| Distributed | AK, AZ, CA, CT, DC, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BM, BR, CA, CH, CN, DE, DZ, EG, ES, FR, GB, HU, ID, IE, IN, IT, JP, KR, KW, LB, MX, NL, NZ, PL, QA, RO, RU, SA, SE, SG, TH, TR, TW, UY |
Product
GE Healthcare, Discovery MR750w
Reason for recall
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
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-2131-2016. 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.