MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 — Class II medical device recall Z-2345-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-08-28, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench
| Recall number | Z-2345-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2019-07-09 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-04-23 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY |
| Quantity | 17 |
| Serial numbers | 166037, 166049, 166082, 166097, 66027, 66028, 66044, 66046, 66047, 66053, 66069, 66082, 66092, 66094, 66102, 66109, 66111 |
| Model numbers | 10849582 |
Product
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Reason for recall
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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-2345-2019. 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.