MAGNETOM Avanto 07391167Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056869006611), received between Feb 17, 2022 and Jul 24, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Device-Device Incompatibility; Insufficient Device Problem Information; Device-Device Incompatibility; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE ASSOCIATED WITH THE MAGNETOM AVANTO SYSTEM. DURING A REVIEW OF THE FDA MAUDE DATABASE PERFORMED BY SIEMENS HEALTHINEERS MR TEAM, MEDWATCH MW5156536 WAS IDENTIFIED. THE MEDWATCH REPORT STATED A PATIENT SUSTAINED 2ND DEGREE (PARTIAL THICKNESS) BURNS TO HIS CHEST FROM 3M ELECTRODES #2570 CONNECTED TO EKG (ELECTROCARDIOGRAM) LEADS DURING THE MRI EXAMINATION ON (B)(6) 2024. THE MEDWATCH REPORT ALSO REFERENCED REPORT MW5156537; HOWEVER, WHEN SEARCHED, THIS REPORT WAS NOT AVAILABLE IN THE MAUDE DATABASE SEARCH. THE MEDWATCH REPORT DID NOT CONTAIN ANY FURTHER INFORMATION. THE REPORTING FACILITY, SYSTEM SERIAL NUMBER, FACILITY CONTACT NAME AND PHONE NUMBER, SEVERITY OF THE PATIENT INJURY, AND ANY MEDICAL TREATMENT THAT MAY HAVE BEEN PROVIDED TO THE PATIENT WERE NOT CONTAINED IN THE MEDWATCH REPORT. THE EVENT WAS NOT REPORTED DIRECTLY TO SIEMENS HEALTHINEERS; THEREFORE, ADDITIONAL INFORMATION CANNOT BE OBTAINED.

  Patient problems: Burn(s)

  MAUDE report 19816228 ↗
• InjuryNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS BECAME AWARE OF A PATIENT INCIDENT. THE PATIENT ALLEGES THAT SHE SUFFERED FRACTURED RIBS WHILE HAVING A BREAST MRI PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18100977 ↗
• InjuryOct 13, 2022Unintended Electrical Shock; Unintended Electrical Shock

  A SEVERE ELECTRICAL SHOCK EVENT OCCURRED WHEN THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS WORKING ON THE MAGNETOM AVANTO ON SEPTEMBER 28, 2022. THE CSE WAS WRAPPING A TEMPERATURE SENSOR WIRE IN THE SEP CABINET WHEN HE SUSTAINED A 480VAC SHOCK. THE SHOCK OCCURRED WHEN THE CSE REACHED INTO THE SEP. THE CSE WAS REPORTEDLY UNABLE TO GET FREE OF THE SEP CABINET AND THE SHOCK LASTED BETWEEN 3-5 SECONDS. THE CSE WAS IMMEDIATELY TREATED AT THE EMERGENCY ROOM WHERE THE CSE UNDERWENT TREATMENT FOR FOUR (4) HOURS. DURING A FOLLOW-UP DOCTOR'S APPOINTMENT ON THE (B)(6), 2022, IT WAS CONFIRMED THAT THE CSE HAD SUSTAINED FOUR (4) ELECTRICAL BURNS IN TOTAL WITH TWO (2) BURNS LOCATED ON THE RIGHT LEG BELOW THE KNEE, ONE (10 BURN ON THE RIGHT BICEP, AND A LARGE (EXACT SIZE UNKNOWN) WOUND THAT BLED ON THE LEFT ARM JUST BELOW THE WRIST. THE DOCTOR PUT THE CSE ON PHYSICAL RESTRICTIONS. AS A RESULT OF THE RESTRICTIONS THE CSE CANNOT WORK TEMPORARILY AND IS ON SHORT TERM DISABILITY. A FOLLOW-UP APPOINTMENT HAS BEEN SCHEDULED, THEREFORE, ADDITIONAL INFORMATION REGARDING THE CSE'S CONDITION IS PENDING.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 15596811 ↗
• InjuryJul 14, 2022Noise, Audible

  ON JULY 4, 2022, IT WAS REPORTED TO SIEMENS THAT A PATIENT COMPLAINED THE MAGNETOM AVANTO SYSTEM NOISE LEVEL DURING EXAMINATION WAS TOO HIGH, EVEN WITH THE HEARING PROTECTION SUPPLIED BY THE TECHNOLOGIST. THE PATIENT ALLEGED THAT THE NOISE DURING THE EXAM CAUSED HIM PAIN AND HYPERACUSIS. THE PATIENT AFFIRMED THE ISSUES ARE PERSISTING. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Acoustic Shock

  MAUDE report 15013063 ↗
• InjuryMar 8, 2022Electromagnetic Compatibility Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE MAGNETOM AVANTO SYSTEM. IT WAS REPORTED THAT A PATIENT SUFFERED A BURN AND AREA OF NECROSIS WHEN USING ECG ELECTRODES. THE INJURIES OCCURRED IN THE AREA OF THE ECG ELECTRODES USED (COVIDIEN KENDALL 630 FOAM ELECTRODES CONDUCTIVE ADHESIVE HYDROGEL, RADIOLUCENT, LOT NUMBER: 000652X). THE PATIENT WAS EVALUATED BY A DERMATOLOGIST FOR CURATIVE CARE AND RELEASED. WE ARE UNAWARE OF ANY FURTHER IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Burn(s)

  MAUDE report 13692972 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE MAGNETOM AVANTO SYSTEM. WHILE MOVING A PATIENT FROM THE MR EXAM ROOM TO THE MR ICU AREA, A MECHANICAL COMPONENT INSIDE THE MR TROLLEY TABLE TOP LATCHING SYSTEM FAILED CAUSING THE TROLLEY TABLE TOP LATCHES TO UNEXPECTEDLY RELEASE. THE TABLE TOP CAME OFF OF THE TROLLEY WITH THE PATIENT ON THE TABLE AND FELL TO THE FLOOR. NO REPORTED INJURIES ARE KNOWN. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549398 ↗