Recall Z-2345-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2345-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-09

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-07-09, terminated 2020-04-23. It names one FDA 510(k) clearance: K132119. 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-09
Terminated: 2020-04-23
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K132119 — MAGNETOM PRISMA, MAGNETOM PRISMA FITSiemens Medical Solutions USA, Inc.·cleared 2013-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.