Siemens recalls MAGNETOM Skyra Fit BioMatrix MRI machines with model 11516217 due to potential ice blockage in helium venting system, risking helium leaks during quenches.
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.
Siemens is recalling specific MAGNETOM Skyra Fit BioMatrix MRI machines that could develop ice blockages in the helium venting system. If a quench occurs, this might cause pressure buildup and rupture of the helium containment system, potentially leaking helium into the scanning room.
Ice blockages in the magnet venting system could prevent helium gas from escaping during a quench. This might cause pressure to build up inside the helium containment system, potentially rupturing it and leaking helium into the scanning room.
Medical facilities using the recalled MAGNETOM Skyra Fit BioMatrix MRI machines with model number 11516217 are at risk. Patients and staff in these facilities could be exposed to helium leaks if the system ruptures.
Check for model number 11516217 on the device. The UDI numbers and serial numbers listed in the recall notice indicate specific units affected.
Look for model number 11516217 on the device label.
The recall is due to a potential ice blockage in the helium venting system that could lead to pressure buildup and rupture during a quench event.
If the helium containment system ruptures, helium could leak into the scanning room, posing a risk to patients and staff.
Check for model number 11516217 on the device. Affected units have specific UDI and serial numbers listed in the recall notice.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2662-2025 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2662-2025 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
