Recall Z-2654-2025— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2654-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-28

Class I · Ongoing

Class I FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-08-28. It names one FDA 510(k) clearance: K200213. Product: Biograph mMR. Model Number: 10433372.. Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class I
Status: Ongoing
Initiated: 2025-08-28
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K200213 — Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.·cleared 2020-05-11

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

Biograph mMR. Model Number: 10433372.

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

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