Siemens recalls BIOGRAPH One (DE) model 11689172 due to potential ice blockage in helium venting system, risking pressure buildup and helium leaks in MRI rooms.
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 its BIOGRAPH One (DE) MRI scanner model 11689172 because ice can block the helium venting system. This could cause pressure buildup and helium leaks in the scanning room if a quench occurs, posing a risk to patients and staff.
Ice blockages in the helium venting system could prevent helium gas from escaping during a quench event. This may cause pressure buildup that ruptures the helium containment system, potentially leaking helium into the scanning room.
Patients and medical staff using the recalled BIOGRAPH One (DE) MRI scanner model 11689172 are at risk. The most vulnerable are those in MRI facilities where the scanner is used for imaging.
Check for the model number 11689172 on the scanner. The recall includes units with UDI numbers starting with (01)4068151020472 or (21)238008.
Look for the model number 11689172 on the scanner or its documentation.
The recall describes a potential ice blockage risk that could lead to pressure buildup and helium leaks, but the exact risk level isn't specified in the record.
Check for the model number 11689172 or UDI numbers starting with (01)4068151020472 or (21)238008.
The recall record does not specify any remedy steps, so no action is required beyond checking if your scanner is affected.
We’ve drafted a message you can send Siemens Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2655-2025 — Siemens Medical Siemens Medical Hello, I own a Siemens Medical that is covered by recall Z-2655-2025 from Siemens Medical. 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.
