Recall Z-2661-2025— 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 6 FDA 510(k) clearances: K250443, K220589, K173592 and 3 more. Product: MAGNETOM Skyra fit. Model Number: 10849580.. 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
6 on FDA's record- K250443 — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
- K220589 — MAGNETOM Skyra Fit
- K173592 — MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
- K162102 — MAGNETOM Avantofit, MAGNETOM Skyrafit
- K151579 — MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
- K130885 — MAGNETOM AVANTO-FIT, 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. Model Number: 10849580.
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.