Siemens recalls MAGNETOM Cima.X Upgrade model 11689304 due to potential ice blockage in helium venting system, risking helium leaks in MRI rooms.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, 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 MAGNETOM Cima.X Upgrade MRI systems with model number 11689304 because ice can block helium venting paths. This could cause pressure buildup and helium leaks in the scanning room if a quench occurs.
Ice blockages in the helium venting system could prevent helium from escaping during a quench event. This might cause pressure buildup that ruptures the helium containment, potentially leaking helium into the scanning room.
MRI facility staff and patients using the recalled MAGNETOM Cima.X Upgrade systems with model number 11689304 are affected. Facilities using this specific model are most at risk.
Check for model number 11689304 on the device. The UDI is (01)04056869975245(21)237304 and serial number 237304.
Look for model number 11689304 on the device.
The recall is due to a potential for ice blockage in the helium venting system, which could cause pressure buildup and helium leaks if a quench occurs.
The recall record does not specify a remedy, so no action is required based on this notice.
The recall record does not describe a risk of serious injury, so the danger level is unknown.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0431-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0431-2026 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.