MAGNETOM Avanto 10849579Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869006659), received between Jul 20, 2022 and Jul 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (1 report).

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

6 other recalls cover devices cleared under the same FDA submission (K130885, K151579, K162102, K181613, K190757, K232494); 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. Sep 1, 2023Class IIOpen, Classified

   In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used

   Z-2648-2023 · Root cause: Process control · 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.

• MalfunctionJul 20, 2022Fire; Fire

  ON (B)(6) 2022, IT WAS REPORTED THAT DURING A PATIENT EXAMINATION USING THE MAGNETOM AVANTO FIT SYSTEM, A LOUD BANG WAS HEARD FROM THE REAR OF THE SYSTEM AND A SMALL AMOUNT OF SMOKE WAS SEEN. THE VLM UNIT DETECTED A HARDWARE MALFUNCTION, AND THE TECHNICIAN REMOVED THE PATIENT. APPROXIMATELY ONE HOUR LATER, A FIRE STARTED IN THE MAGNET ROOM AT THE BACKSIDE OF THE SYSTEM MAGNET. THE SYSTEM WAS SWITCHED OFF BY THE VLM. THE LOCAL FIRE DEPARTMENT WAS CALLED, AND THE FIREFIGHTERS QUENCHED THE SYSTEM USING THE ERDU BUTTON AND SWITCHED OFF THE POWER (EPO). THE FIREFIGHTERS EXTINGUISHED THE FIRE IN THE ROOM AND SYSTEM. THE CUSTOMER SERVICE ENGINEER FOUND A BROKEN Y-GRADIENT CABLE ON THE GRADIENT CONNECTION PLATE AT THE BACKSIDE OF THE MAGNET. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT. ON JULY 8, 2022, A SIEMENS EXPERT VISITED THE SITE AND INFORMED SIEMENS ABOUT THE EXTENT OF THE FIRE. ALL COMPONENTS OF THE SYSTEM LOCATED IN THE MAGNET ROOM ARE DAMAGED BY THE FIRE, THE SMOKE, AND THE EXTINGUISHING WATER. THE REPORTED EVENT OCCURRED IN THE NETHERLANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064247 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130885, K151579, K162102, K181613, K190757, K232494. One submission often covers many models, so check the product and lot details in each record.

• Z-2659-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2665-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot. Model Number: 10684333.
• Z-2662-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
• Z-2666-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
• Z-2661-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra fit. Model Number: 10849580.
• Z-0467-2016 · Dec 7, 2015 · Terminated
  MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).