MSK 1 — Class II medical device recall Z-1927-2016
Terminated recall by GE Healthcare, LLC, reported 2016-06-15, distributed in AL, AZ, CA, CO, FL, IA, ID, IL…. The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryo
| Recall number | Z-1927-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-05-09 |
| Classified | 2016-06-08 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2018-07-11 |
| Distributed | AL, AZ, CA, CO, FL, IA, ID, IL, ME, NC, NE, NH, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BR, CA, CH, CL, CO, DE, DK, EG, ES, FI, FR, GB, GR, HK, IS, IT, JP, KR, KW, MY, NL, NO, PE, PL, PT, RU, SE, SG, UA, ZA |
| Quantity | 97 |
Product
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
Reason for recall
The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
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-1927-2016. 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.