MAGNETOM Avanto 10684332Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869006635), received between Oct 28, 2020 and Aug 26, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K032428, K052164, K052423, K062454, K121434, K130885); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A RIB INJURY TO A PATIENT UNDERGOING A BREAST MRI EXAM USING A MAGNETOM AVANTO SYSTEM. ALLEGEDLY, THE PATIENT HAD HIGH BODY MASS LIMITING THE SPACE INSIDE THE MRI BORE. THE PATIENT ALLEGEDLY PANICKED INSIDE THE BORE THRASHING AND COMPLAINING OF A RIB INJURY. OUR INVESTIGATION COULDN¿T CONFIRM THE EXACT NATURE AND EXTENT OF THE ALLEGED INJURY AND WHETHER IT NEEDED ANY MEDICAL ATTENTION OR INTERVENTION.

  Patient problems: Bone Fracture(s)

  MAUDE report 22892962 ↗
• InjuryDec 15, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT WAS INJURED DURING MOVEMENT INTO THE GANTRY AFTER THE PATIENT POSITIONING PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY SIEMENS ON DECEMBER 13, 2022, CLARIFIED THAT THE PATIENT'S FIFTH DIGIT ON THE RIGHT HAND BECAME STUCK BETWEEN TABLETOP AND BODY COIL. ACCORDING TO THE HOSPITAL STAFF, SOFT TISSUE SWELLING OF THE DIGIT WAS OBSERVED AT THE TIME OF INCIDENT. FURTHERMORE, IT WAS STATED THAT THERE WAS A LACERATION WHICH REQUIRED THREE (3) SUTURES AND THE DIGIT WAS DISLOCATED. THE PATIENT REQUIRED A SURGICAL PROCEDURE TO RESOLVED SEVERE ULNAR DEVIATION OF THE METACARPOPHALANGEAL JOINT OF THE FIFTH DIGIT.

  Patient problems: Joint Dislocation; Laceration(s)

  MAUDE report 15988001 ↗
• InjuryOct 28, 2020Improper 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. DURING TABLE MOVEMENTS, A PATIENT´S FINGER TIP WAS CAUGHT BETWEEN THE TABLETOP AND TROLLEY. AS A RESULT, THE PATIENTS FINGER TIP WAS SEVERED. THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM AND SURGERY WAS PERFORMED TO REATTACH THE SEVERED TISSUE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Skin Tears

  MAUDE report 10747159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032428, K052164, K052423, K062454, K121434, K130885. One submission often covers many models, so check the product and lot details in each record.

• Z-2661-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra fit. Model Number: 10849580.
• Z-2665-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot. Model Number: 10684333.
• Z-2666-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
• Z-0467-2016 · Dec 7, 2015 · Terminated
  MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
• 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-2021-2011 · Mar 3, 2011 · Terminated
  MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.
• Z-1528-05 · Aug 12, 2005 · Terminated
  Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167
• Z-1395-04 · Jul 28, 2004 · Terminated
  Magnetom Avanto MRI System, Model 7391167