FDA Device recall Z-2345-2019
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 by Siemens Medical Solutions Usa, citing potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2345-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-09 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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 |
Product
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Reason
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
Identifiers
| code_info | Serial # 66109 66111 166049 66047 166037 66102 66027 66053 66094 66028 66069 66092 66046 66082 166097 66044 166082 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2345-2019%22
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