MAGNETOM Avanto 10684331Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869006628), received between Jul 10, 2020 and Apr 15, 2024 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Electromagnetic Compatibility Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Electromagnetic Compatibility Problem; Excessive Heating; Electromagnetic Compatibility Problem; Excessive Heating

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT BURN EVENT DURING AN MRI EXAMINATION ON THE MAGNETOM AVANTO DOT SYSTEM. ACCORDING TO THE RECEIVED INFORMATION, THE ECG ELECTRODES ATTACHED TO THE PATIENT WERE MR SAFE, BUT THERE WERE ECG CABLES ATTACHED TO THE ELECTRODES WERE NOT MR SAFE. THE CABLES ARE CUSTOMER OWNED AND WERE NOT SUPPLIED BY SIEMENS HEALTHINEERS. DURING THE EXAMINATION, THE PATIENT HAD BEEN SEDATED. THE PATIENT NOTICED FOUR (4) BURN MARKS WITH BLISTERS ON HIS CHEST WHEN HE ARRIVED HOME. THE BURN MARKS APPEARED WHERE THE ELECTRODES HAD BEEN POSITIONED. AS OF THE DATE OF THIS REPORT, SIEMENS HEALTHINEERS WAS NOT PROVIDED WITH MORE DETAILED INFORMATION REGARDING THE SEVERITY OF THE BURN INJURIES, PATIENT HEALTH STATUS, OR MEDICAL TREATMENT WHICH MAY HAVE BEEN PROVIDED. AS OF THE DATE OF THIS REPORT, SIEMENS HEALTHINEERS CANNOT EXCLUDE WITH ABSOLUTE CERTAINTY THAT A SERIOUS INJURY OCCURRED DURING THE PATIENT EXAMINATION.

  Patient problems: Burn(s)

  MAUDE report 19103983 ↗
• InjuryJan 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS INITIALLY REPORTED TO SIEMENS THAT A PATIENT COMPLAINED OF A "SUDDEN DEAFNESS" AFTER AN MRI EXAMINATION WITH THE MAGENETOM AVANTO DOT UPGRADE SYSTEM ON (B)(6) 2022. THE PATIENT REPORTEDLY INFORMED THE HOSPITAL OF THE DEAFNESS ON (B)(6) 2022. THE ISSUE WAS NOT REPORTED TO SIEMENS AT THAT TIME. THE EVENT WAS REPORTED TO SIEMENS ON (B)(6) 2023 AND ADDITIONAL INFORMATION ABOUT THE EVENT TO DETERMINE REPORTABILITY WAS NOT RECEIVED BY SIEMENS UNTIL (B)(6) 2023 AND (B)(6) 2023. THE ADDITIONAL INFORMATION CLARIFIED THAT THE PATIENT UNDERWENT A BRAIN SCAN FOR HEADACHES, DIZZINESS, AND INSOMNIA ON (B)(6) 2022. FURTHERMORE, IT WAS CLARIFIED THAT HEARING IMPAIRMENT AND HYPOACUSIS WOULD BE THE MORE SUITABLE TERMS FOR THE PATIENT'S CONDITION THAN INITIALLY REPORTED TERM "SUDDEN DEAFNESS". IT WAS ALSO CONFIRMED THAT THE PATIENT HAD WORN EAR PLUGS AND MRI HEADPHONES DURING THE SCAN IN COMPLIANCE WITH THE INSTRUCTIONS OF THE SYSTEM OPERATOR MANUAL AND THE COMPLAINT MRI SYSTEM IS WITHIN SPECIFICATION. IT IS UNCLEAR IF THE PATIENT HAS HAD ANY HEARING ISSUES BEFORE THE SCAN. IT WAS STATED THAT THERE WAS NO HEARING IMPAIRMENT RIGHT AFTER THE MRI SCAN ON (B)(6) 2022. ON THE NEXT DAY, (B)(6) 2022,

  Patient problems: Hearing Impairment

  MAUDE report 16188234 ↗
• DeathOct 25, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM AVANTO DOT SYSTEM. IT WAS STATED THAT AN IRON DISK USED TO IMMOBILIZE ORGANS AFTER SURGICAL INTERVENTION WAS ATTRACTED TO THE MAGNET AND INJURED THE PATIENT. THE PATIENT SUFFERED A LACERATION TO THE JAW. THE SEVERITY OF THE INJURY OR APPLIED MEDICAL INTERVENTION IS NOT KNOWN. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Laceration(s)

  MAUDE report 12688097 ↗
• InjuryJul 10, 2020Use of Device Problem; Use of Device Problem

  SIEMENS WAS NOTIFIED ABOUT AN INCIDENT THAT OCCURRED ON THE MAGNETOM AVANTO DOT SYSTEM. A PATIENT COMPLAINED OF DETERIORATION OF HIS ACL INJURY. IN 2009 THE PATIENT WENT THROUGH A MEDICAL PROCEDURE THAT INCLUDED INSERTION OF METAL PIECES FOR HIS ACL INJURY. THE PATIENT MADE FULL RECOVERY FOLLOWING THE PROCEDURE. (B)(6) 2019, THE PATIENT HAD AN MRI SCAN OF HIS SHOULDER ON THE MAGNETOM AVANTO DOT DEVICE. DURING THE SCAN THE PATIENT FELT VERY STRONG PERIPHERAL NERVE STIMULATION IN THE HANDS, FEET, AND EVEN ALONG THE SCAR OF THE PREVIOUS ACL REPAIR. FOLLOWING THE MRI EXAM PATIENT IS EXPERIENCING "KNEE STIFFNESS ACCOMPANIED BY SEVERE PAIN IN THE SHINBONE AND A FEELING OF A CORD CUTTING VERTICALLY ACROSS THE BACK OF THE KNEE AND A COLD FEELING ACROSS THE UPPER BACK OF THIGH AND LOUD POPPING AND CLICKING UPON SLIGHT ROTATIONS". AS A MEDICAL INTERVENTION THE PATIENT RECEIVED PHYSIOTHERAPY SEVERAL TIMES. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 10257601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121434. 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-2665-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot. Model Number: 10684333.
• 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