Recall Z-2662-2025— Siemens Medical Solutions USA, Inc
Class I · Ongoing
Class I FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-08-28. It names 3 FDA 510(k) clearances: K250443, K232494, K220589. Product: MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.. 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
3 on FDA's record- K250443 — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
- K232494 — MAGNETOM Avanto fit; MAGNETOM Skyra fit
- K220589 — MAGNETOM Skyra Fit
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 Skyra Fit BioMatrix. Model Number: 11516217.
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.