MAGNETOM Vida 11060815Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04056869039176), received between Mar 17, 2022 and Mar 18, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

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-2667-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Detachment of Device or Device Component

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE AND A POTENTIAL INJURY ASSOCIATED WITH THE MAGNETOM VIDA SYSTEM. IT WAS STATED THAT THE TUI HANDLE BROKE AS A TECHNICIAN ATTEMPTED TO PULL THE TABLE OUT OF THE DOCKING STATION. AS THE HANDLE BROKE, THE TECHNICIAN LOST BALANCE, FELL BACKWARD, AND LANDED ON THE FLOOR. THE TECHNICIAN STATED THE FALL RESULTED IN RADIATING BACK PAIN. ALTHOUGH REQUESTED, DETAILED INFORMATION REGARDING THE SEVERITY OF THE INJURY, MEDICAL INTERVENTION PROVIDED, AND CURRENT HEALTH STATUS OF THE TECHNICIAN HAS NOT BEEN PROVIDED TO SIEMENS HEALTHINEERS AS OF THE DATE OF THIS REPORT.

  Patient problems: Back pain

  MAUDE report 24627294 ↗
• InjuryMar 16, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM VIDA SYSTEM. INJURY INFORMATION WAS PROVIDED FOR TWO PATIENTS. PATIENT 1 SUSTAINED A SECOND DEGREE BURN ON THE LEFT BREAST (SIZE APPROX. 5 CM X 2 CM). ALTHOUGH REQUESTED, NO INFORMATION ABOUT MEDICAL TREATMENT HAS BEEN PROVIDED FOR THIS PATIENT. PATIENT 2 ALSO SUSTAINED A SECOND DEGREE BURN ON THE LEFT BREAST (SIZE APPROX. 5 CM X 2 CM). WITHIN 24 HOURS FOLLOWING THE BIOPSY, A BLISTER APPEARED AT THE BIOPSY SITE AND SUBSEQUENTLY EVOLVED INTO A SKIN ULCERATION. THE PATIENT UNDERWENT A LUMPECTOMY FIVE DAYS AFTER THE BIOPSY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION ABOUT MEDICAL TREATMENT OF THE BURN WAS PROVIDED. ADDITIONALLY, IT WAS STATED IN THE PROVIDED QUESTIONNAIRES THAT THERE WERE FIVE OCCURRENCES IN TOTAL. NO INJURY INFORMATION HAS BEEN PROVIDED FOR THE OTHER THREE PATIENTS AS OF THE DATE OF THIS REPORT. BASED ON THE INFORMATION RECEIVED AS OF THE DATE OF THIS REPORT, SIEMENS HEALTHINEERS CANNOT EXCLUDE A SERIOUS INJURY OCCURRED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24613648 ↗
• MalfunctionDec 23, 2025Device Handling Problem; Device Handling Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL INJURY INVOLVING THE MAGNETOM VIDA SYSTEM. ACCORDING TO THE COMPLAINT REPORT A FERROMAGNETIC IRON BLOCK WAS ATTRACTED TO THE MAGNET. NO INFORMATION HAS BEEN PROVIDED TO DATE IF AN INJURY HAS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23876618 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM VIDA MR SYSTEM. IT WAS STATED THAT A PATIENT HEATING INCIDENT OCCURRED IN WHICH THE PATIENT HAD A BURN TO THE THIGHS, ALTHOUGH NO DETAILED INFORMATION ABOUT THE BURN OR MEDICAL TREATMENT IS AVAILABLE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT; HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THIS DATE. THEREFORE, THIS EVENT IS BEING REPORTED IN THE ABUNDANCE OF CAUTION.

  Patient problems: Burn(s)

  MAUDE report 23346417 ↗
• InjuryAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL PATIENT INJURY INVOLVING THE MAGNETOM VIDA SYSTEM. PER THE RECEIVED INFORMATION THE PATIENT DID NOT FEEL ANY BURN, BUT ONLY SOME HEAT DURING THE EXAMINATION; HOWEVER, THE PATIENT NOTICED BURNS ON THE LOWER BACK TWO HOURS AFTER THE EXAMINATION. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE EVENT DETAILS AND THE EXTENT OF THE PATIENT¿S INJURY. THE ADDITIONAL INFORMATION IS PENDING RECEIPT AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 22781820 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INCIDENT INVOLVING THE MAGNETOM VIDA SYSTEM VIA VOLUNTARY MEDWATCH REPORT NUMBER MW5172356, SUBMITTED BY THE PATIENT TO THE FDA. SIEMENS HEALTHINEERS CONTACTED THE PATIENT AND THE FACILITY THE MRI WAS PERFORMED AT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT UNDERWENT A TEMPOROMANDIBULAR JOINT (TMJ) MRI EXAMINATION WITH A HEAD COIL ON (B)(6) 2025. THE PATIENT HAD UNDERGONE BACK SURGERY DURING (B)(6) 2009 DURING WHICH STAINLESS STEEL RODS AND SCREWS WERE IMPLANTED. PATIENT UNDERWENT THIS SURGERY AT (B)(6). THE PATIENT WAS TOLD THAT THE IMPLANTS WERE MRI COMPATIBLE IN (B)(6) 2024. THE REASON FOR THE SURGERY WAS NOT STATED. DURING A MEASUREMENT PAUSE, THE PATIENT MENTIONED WARMING AND TINGLING TO THE MRI TECHNICIAN AND THE IMAGING WAS COMPLETED. THE PATIENT STATED THAT HE COULD FEEL HEAT THROUGH HIS SKIN DURING THE FIRST DAY AFTER THE SCAN ((B)(6) 2025), THEN HAS BEEN EXPERIENCING ONGOING PAIN, DISCOMFORT, AND TIGHTNESS IN THE BACK AND NECK FOR THE LAST TWO MONTHS. THE PATIENT CONTACTED THE MRI FACILITY ON (B)(6) 2025 TO REPORT HIS CONCERNS AND TO ASK QUESTIONS REGARDING HIS PROCEDURE (SAR LEVEL, ETC.). THE PATIENT STATES HE COULD NOT LI

  Patient problems: Back pain; Discomfort

  MAUDE report 22685500 ↗
• InjuryMay 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE ASSOCIATED WITH THE MAGNETOM VIDA SYSTEM. IT WAS STATED THAT A FERROMAGNETIC STOOL WAS ATTRACTED TO THE MAGNET; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTING FACILITY. IT IS UNKNOWN, AS OF THE DATE OF THIS REPORT, IF THE EVENT RESULTED IN PATIENT OR STAFF INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS PENDING RECEIPT BY SIEMENS HEALTHINEERS. DUE TO THE RISK OF SERIOUS INJURY POSED BY THE ATTRACTION OF THE STOOL TO THE MAGNET, SIEMENS HEALTHINEERS IS REPORTING THIS ISSUE AS A POTENTIAL ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22034402 ↗
• InjuryMay 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY WHILE UNDERGOING AN EXAMINATION WITH THE MAGNETOM VIDA SYSTEM. THE PATIENT FELT A BURNING SENSATION ON THEIR HEAD DURING THE EXAMINATION WHICH INCLUDED A HEAD/NECK 20 COIL. THE PATIENT HAD PUT HER STOLE UNDERNEATH HER HEAD DURING THE EXAMINATION. THE PATIENT¿S HAIR WAS BURNT, AND A YELLOW MARK WAS VISIBLE ON THE HEAD COIL. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION IS NOT AVAILABLE. IT IS UNKNOWN IF THE PATIENT SUSTAINED INJURY. ADDITIONAL INFORMATION REGARDING THE EVENT AND THE PATIENT¿S HEALTH STATUS HAS BEEN REQUESTED.

  Patient problems: Skin Burning Sensation

  MAUDE report 22025677 ↗
• InjuryNov 7, 2023Use of Device Problem; Use of Device Problem

  SIEMENS HEALTHINEERS WAS INFORMED THAT A FERROMAGNETIC CRUTCH WAS ATTRACTED TO THE MAGNET IN THE MR ROOM, SERIOUSLY INJURING THE PATIENT. THE PATIENT SUFFERED LACERATIONS, BLEEDING, AND A LOST TOOTH. THE PATIENT WAS TAKEN TO AN AMBULANCE BY PARAMEDICS. NO FURTHER INFORMATION IS AVAILABLE AS OF THE DATE OF THIS REPORT REGARDING THE PATIENT'S CURRENT HEALTH STATUS. SIEMENS IS AWAITING ADDITIONAL INFORMATION WITH RESPECT TO THE PATIENT¿S INJURIES AND PROVIDED MEDICAL INTERVENTION.

  Patient problems: Laceration(s); Tooth Fracture

  MAUDE report 18082953 ↗
• InjuryDec 15, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT'S HAND WAS INJURED AFTER AN EXAMINATION USING THE MAGNETOM VIDA SYSTEM. WOODEN STEPS WERE LOCATED ON THE RIGHT SIDE OF THE PATIENT TABLE (PATAB). THE PATIENT PUT HIS RIGHT HAND ON THE EDGE OF THE PATAB WHEN THE TABLE WAS BEING LOWERED AND THE PATIENT'S FINGERS WERE CAUGHT BETWEEN THE EDGE OF THE PATIENT TABLE AND THE WOODEN STEPS. PATIENT'S RIGHT HAND MIDDLE FINGER WAS FRACTURED AND BOTH MIDDLE FINGER AND FOURTH FINGER SUFFERED SOFT TISSUE INJURY. THE INJURIES WERE TREATED WITH 20 SUTURES IN TOTAL, THE AVULSED SKIN WAS REGRAFTED, AND THE HAND WAS IMMOBILIZED.

  Patient problems: Bone Fracture(s); Laceration(s)

  MAUDE report 15993096 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE MAGNETOM VIDA MR SYSTEM. INITIALLY IT WAS STATED THAT A PATIENT UNDERWENT AN MRI ON (B)(6) 2022. AFTER SOME TIME HAD PASSED AFTER THE EXAMINATION, THE PATIENT SENT A LETTER TO THE HOSPITAL ALLEGING THAT THEY PARTLY LOST HEARING AFTER THE MRI EXAMINATION. THE PATIENT LETTER WAS DATED (B)(6) 2022 AND WAS PROCESSED INTERNALLY AT THE HOSPITAL BEFORE SIEMENS WAS MADE AWARE OF THIS INCIDENT ON (B)(6) 2022. IT WAS FURTHER CLARIFIED THAT THE PATIENT PREVIOUSLY HAD TINNITUS IN THEIR LEFT EAR BEFORE THE MRI EXAMINATION. AFTER THE MRI EXAMINATION, THE PATIENT OBSERVED TINNITUS IN BOTH EARS. THE TINNITUS INCREASED TO A 7/10 WHILE THE AUDITION WAS DECREASED. DURING THE EXAMINATION THE PATIENT'S HEARING WAS PROTECTED WITH REGULAR EAR PLUGS AS WELL AS PROVIDED MINI EAR MUFFS. PADDING WAS PROVIDED AROUND THE HEAD TO KEEP THE HEAD STABLE IN THE HEAD COIL AND TO REDUCE THE NOISE AS THE HEADPHONES DID NOT FIT INTO THE HEAD COIL. AT THIS TIME IT IS UNCLEAR IF THE INCREASED TINNITUS IN THE LEFT EAR AND THE NEW TINNITUS IN THE RIGHT EAR IS TEMPORARY OR PERMANENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER T

  Patient problems: Partial Hearing Loss; Tinnitus

  MAUDE report 13791561 ↗