Recall Z-2660-2025— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2660-2025
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 2 FDA 510(k) clearances: K231560, K101347. Product: MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.. 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

2 on FDA's record

K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc.·cleared 2023-10-23
K101347 — MAGNETOM AERA; MAGNETOM SKYRASiemens Medical Solutions USA, Inc.·cleared 2010-10-01

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 (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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.