MAGNETOM Skyra Fit 11516217Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869299273), received between Feb 16, 2026 and Feb 16, 2026 — classified as 1 injury.

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

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

1 other recall cover devices cleared under the same FDA submission (K220589, K250443); 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.

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-2662-2025 · 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM SKYRA FIT BIOMATRIX SYSTEM. IT WAS STATED THAT A PATIENT SUSTAINED A 2ND DEGREE BURN ON THEIR RIGHT ARM. THE BURN WAS TREATED IN HOSPITAL EMERGENCY ROOM, BUT NO DETAILS ABOUT THE TREATMENT WERE PROVIDED. SIEMENS HEALTHINEERS HAS RECEIVED THE INFORMATION THAT THE CUSTOMER DOES NOT HAVE ANY ADDITIONAL DETAILS REGARDING THE PATIENT'S INJURY AS THE PATIENT WAS TREATED AT A DIFFERENT (BETTER EQUIPPED) HOSPITAL. SIEMENS HEALTHINEERS CANNOT EXCLUDE THAT A SERIOUS INJURY OCCURRED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24344680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220589, K250443. 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.