Recall Z-2658-2025— 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 4 FDA 510(k) clearances: K231560, K203443, K192924 and 1 more. Product: MAGNETOM Lumina (DE). Model Number: 11344916.. 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
4 on FDA's record- K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
- K203443 — MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
- K192924 — MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
- K183244 — MAGNETOM Lumina
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 Lumina (DE). Model Number: 11344916.
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.