Siemens recalls MAGNETOM Lumina (DE) model 11344916 due to potential ice blockage in helium venting system that could cause pressure build-up and helium leaks during quench events.
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 models of their MAGNETOM Lumina (DE) MRI scanners because ice can block the helium venting system. If a quench occurs (a sudden release of helium), this could cause pressure buildup that might rupture the helium containment system and leak helium into the scanning room.
The scanner's helium venting system could become blocked by ice, preventing helium from escaping during a quench event. This may cause pressure buildup that could rupture the helium containment system, potentially leaking helium into the scanning room.
Medical facilities using the recalled MAGNETOM Lumina (DE) MRI scanners with model number 11344916 are affected. Patients and staff at these facilities are at risk if a quench event occurs due to the potential helium leak.
Check for the model number 11344916 on the scanner. The UDI numbers listed in the recall include specific sequences starting with (01)04056869230740(21) followed by numbers like 196458, 196591, etc. Serial numbers are also listed in the recall.
Verify the model number on your scanner is 11344916 to determine if it's affected.
Reach out to Siemens Medical Solutions USA, Inc. for guidance on next steps if your scanner is affected.
If a quench occurs, ice blockage in the helium venting system could cause pressure buildup that might rupture the helium containment system, potentially leaking helium into the scanning room.
Check for model number 11344916 on your scanner. Affected units have specific UDI numbers starting with (01)04056869230740(21) followed by numbers like 196458, 196591, etc.
Contact Siemens Medical Solutions USA, Inc. for guidance on next steps if your scanner is affected.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2658-2025 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2658-2025 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.
