Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2666-2025 — MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

U.S. FDA — Device Enforcement · United States · 2025-08-28 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2666-2025
Date of alert
2025-08-28
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10684334
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.