MAGNETOM Cima.X Upgrade. Model Number: 11689304.
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.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- MAGNETOM Cima.X Upgrade. Model Number: 11689304.
- Sold in
- US distribution to California. International distribution to Australia, Germany, Great Britian.
- Made for
- All ages (0 months and older)
Details
- Units affected
- 4 system (1 US; 3 OUS)
- Illnesses reported
- None reported
- Manufactured in
- 40 Liberty Blvd, Malvern, PA, United States
- Classification
- Class I
- Recall number
- Z-0431-2026
In the FDA's words
- Description
- MAGNETOM Cima.X Upgrade. Model Number: 11689304. 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. Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304. Distribution: US distribution to California. International distribution to Australia, Germany, Great Britian. Affected quantity: 4 system (1 US; 3 OUS)
- Hazard
- 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.
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