FDA Device recall Z-2661-2025

MAGNETOM Skyra fit

• FDA Device
• Class I
• ongoing
• Published 2025-10-08

On 2025-10-08 the FDA classified a Class I recall of MAGNETOM Skyra fit by Siemens Medical Solutions Usa, citing 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 desi….

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2661-2025%22

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