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[Recalled] MAGNETOM Verio Dot Upgrade. Model Number: 10684334. — There is a potential for an ice blockage to form or currently exist within the… | FDA 2025-08-28

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductMAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Brand / manufacturerSiemens Medical Solutions USA, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2666-2025
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date28 August 2025
EAN / barcode10684334

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Siemens Medical Solutions USA, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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