MAGNETOM Vida Fit 11410481Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869245188), received between Oct 24, 2022 and Oct 24, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

3 FDA recall records name this device's identifier, 3 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-2668-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2654-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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.

• InjuryOct 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN INCIDENT OCCURRED AFTER A PATIENT EXAMINATION WITH THE MAGNETOM VIDA FIT SYSTEM ON (B)(6), 2022. ON (B)(6), 2022, ADDITIONAL INFORMATION WAS RECEIVED BY SIEMENS REGARDING THE INCIDENT AND BASED ON THIS INFORMATION IT WAS DETERMINED THE COMPLAINT WAS REPORTABLE. PER THE COMPLAINT REPORT THERE WAS A SERIOUS INJURY ASSOCIATED WITH THIS ISSUE. IT WAS STATED THAT A PATIENT WITH EAR EPITHESIS PINS WAS EXAMINED WITH A 3 T MRI. AFTERWARDS THE EPITHESIS PINS IN THE PATIENT'S EARS WERE NO LONGER MAGNETIC. TO REPLACE THE EPITHESIS PINS A SURGICAL PROCEDURE IS NECESSARY. THE PATIENT HAS HAD PREVIOUS EXAMINATIONS WITH 3 T MRI SYSTEMS DURING WHICH THE EPITHESIS PINS WERE NOT AFFECTED. ALTHOUGH THE RELATION BETWEEN THE LAST MRI EXAMINATION AND THE LOSS OF MAGNETISM OF THE PATIENT'S EAR EPITHESIS PINS IS UNCLEAR, SIEMENS DECIDED TO REPORT THIS INCIDENT WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN GERMANY.

  Patient problems: Failure of Implant

  MAUDE report 15657330 ↗