MAGNETOM Verio 10684334Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869006680), received between Mar 16, 2023 and Mar 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (1 report).

3 FDA recall records name this device's identifier, 3 still open.

6 other recalls cover devices cleared under the same FDA submission (K072237, K121434); 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-2666-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2660-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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-2661-2025 · 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.

• InjuryMar 16, 2023Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  IT WAS REPORTED TO SIEMENS THAT A SERIOUS INJURY OCCURRED DURING A PATIENT EXAMINATION ON (B)(6) 2023. THE MRI TECHNICIAN SUSTAINED A SERIOUS INJURY DUE TO AN OXYGEN CYLINDER BECOMING STUCK TO THE MAGNET OF THE MAGNETOM VERIO SYSTEM.THE MRI TECHNICIAN SUSTAINED A SEVERE ABDOMINAL INJURY DURING THIS EVENT AND HAD TO UNDERGO LIFE-SAVING EMERGENCY SURGERY TO TREAT THE INJURY. AS OF MARCH 13, 2023, SIEMENS HAS RECEIVED ADDITIONAL INFORMATION STATING THE INJURED MRI TECHNICIAN IS STILL IN THE FACILITY'S INTENSIVE CARE UNIT. THE PATIENT PRESENT DURING THE EVENT ON (B)(6) 2023 WAS NOT INJURED.

  Patient problems: Crushing Injury

  MAUDE report 16551708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072237, K121434. One submission often covers many models, so check the product and lot details in each record.

• Z-2665-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot. Model Number: 10684333.
• Z-2664-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio. Model Number: 10276755.
• 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
• Z-2464-2012 · Sep 12, 2012 · Terminated
  Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
• Z-1364-2012 · Mar 26, 2012 · Terminated
  Siemens MAGNETOM Verio Use: Nuclear resonance imaging system
• Z-1401-2011 · Jan 10, 2011 · Terminated
  MAGNETOM Verio Nuclear magnetic resonance imaging