MAGNETOM Skyra 10849580Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869006710), received between Jul 28, 2023 and Jun 10, 2025 — classified as 2 injuries.

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

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

3 other recalls cover devices cleared under the same FDA submission (K130885, K140253, K141977, K142515, K151579, K162102, K173592, K232494); 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-2661-2025 · 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Device Handling Problem; Device Handling Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A SERIOUS PATIENT INJURY ASSOCIATED WITH THE MAGNETOM SKYRA FIT SYSTEM. IT WAS STATED IN THE COMPLAINT THE PATIENT UNDERWENT A PELVIC SCAN ON (B)(6) 2025. DURING THE EXAMINATION, THE PATIENT PRESSED TO THE SQUEEZE BALL TO INDICATE A SENSATION OF HEAT BETWEEN HER THIGHS. THE MR TECHNOLOGIST INSPECTED THE AREA AND ASKED THE PATIENT TO MOVE HER LEGS FURTHER APART. THE TECHNOLOGIST CONTINUED THE MRI EXAMINATION. THE PATIENT INFORMED THE HOSPITAL ON (B)(6) 2025 THAT AFTER THE PELVIC EXAMINATION THERE WAS REDNESS BETWEEN THE THIGHS WHICH EVOLVED INTO BLISTERS ON BOTH THIGHS THAT WERE ABOUT 2 CM EACH. THE PATIENT SENT PICTURES OF THE WOUNDS TO THE HOSPITAL. THE WOUNDS WERE TREATED AS BURNS AND WERE TREATED WITH COMPRESSES AND BURN OINTMENT. THE INJURY PERSISTED APPROXIMATELY 10 DAYS AFTER THE INITIAL SCAN. SIEMENS HEALTHINEERS WAS NOTIFIED OF THE EVENT ON (B)(6) 2025. SIEMENS DETERMINED THIS ISSUE TO BE A SERIOUS INJURY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22177737 ↗
• InjuryJul 28, 2023Use of Device Problem; Use of Device Problem

  SIEMENS HEALTHINEERS WAS MADE AWARE OF A PATIENT INCIDENT AFTER AN EXAMINATION USING THE MAGNETOM SKYRA FIT 3 TESLA MRI SYSTEM. PATIENT CLAIMS THAT AFTER THE SCAN HE NOTICED LOUD RINGING IN HIS EARS, AND ON AN UNKNOWN DAY IN (B)(6) 2021 HE WAS DIAGNOSED WITH HEARING LOSS. THE PATIENT STATES THAT THE HEADPHONES HE ALLEGED AS BEING USED DURING HIS EXAMINATION ARE ADVERTISED AS HAVING 14-DECIBEL SOUND REDUCTION AND THAT THE SKYRAFIT 3 TESLA MANUAL (DOCUMENT NAME NUMBER NOT PROVIDED TO SIEMENS) SPECIFIES THAT 30-DECIBEL OR MORE SOUND REDUCTION IS NEEDED FOR PATIENTS. THE EVENT DETAILED COULD NOT BE CONFIRMED BY SIEMENS. THE SIEMENS HEALTHINEERS REGIONAL SERVICE MANAGER (RSM) WAS NOTIFIED OF THE EVENT AND STATED THAT THE CUSTOMER FACILITY SYSTEM IS NOT SERVICED BY SIEMENS SERVICE ORGANIZATION BUT BY A THIRD-PARTY SERVICE PROVIDER. IT IS UNKNOWN WHAT HEADPHONES ARE USED AT THE CUSTOMER FACILITY AS IT IS NOT SERVICED BY SIEMENS HEALTHINEERS. SIEMENS HEALTHINEERS RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER FACILITY RISK MANAGER STATING THE FOLLOWING: THE PATIENT WAS EXAMINED AT THEIR FACILITY USING A ROUTINE MR PROSTATE PROTOCOL AND HAS NOT BEEN SEEN AT THE FACILITY SINCE OCTOBER 202

  Patient problems: Hearing Impairment

  MAUDE report 17415528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130885, K140253, K141977, K142515, K151579, K162102, K173592, K232494. One submission often covers many models, so check the product and lot details in each record.

• Z-2659-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2662-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
• Z-0467-2016 · Dec 7, 2015 · Terminated
  MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).