MAGNETOM Verio 10684333Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869006673), received between Dec 8, 2025 and Dec 8, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K121434, K181613); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 28, 2025Class IOpen, Classified

   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.

   Z-2665-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS WAS INFORMED ABOUT AN ADVERSE EVENT THAT OCCURRED WHILE OPERATING THE MAGNETOM VERIO SYSTEM. DURING A PROSTATE SCAN WITH A FLEX COIL, THE PATIENT RECEIVED A POSSIBLE SKIN BURN. ADDITIONAL INFORMATION ABOUT THE EVENT WAS REQUESTED BY THE USER AND THE CUSTOMER'S SERVICE PROVIDER. HOWEVER, THIS INFORMATION HAS NOT BEEN RECEIVED TO THIS DATE. SIEMENS IS CONDUCTION AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Burn(s)

  MAUDE report 23742131 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121434, K181613. One submission often covers many models, so check the product and lot details in each record.

• Z-2666-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
• Z-1308-2015 · Mar 9, 2015 · Terminated
  MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal