MAGNETOM Skyra 10432915Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056869006703), received between Jan 25, 2022 and Apr 13, 2026 — classified as 7 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.

8 other recalls cover devices cleared under the same FDA submission (K111242, K123510, K130885, K133435, K140253, K141977, K142515, K153343, K163312, K173592, K202014, K231560); 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-2660-2025 · 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A PATIENT EXPERIENCED POTENTIAL BURNS AS A RESULT OF AN MRI EXAMINATION ON THE MAGNETOM SKYRA. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Skin Burning Sensation

  MAUDE report 24856669 ↗
• MalfunctionJul 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED THAT THE MAGNETOM SKYRA MAGNET RUPTURED AFTER THE SYSTEM QUENCHED. CONSEQUENTLY, HELIUM ENTERED THE EXAMINATION ROOM. THERE WAS SIGNIFICANT DAMAGE TO THE EXAMINATION ROOM, CONTROL ROOM, AND THE WAITING AREA. ACCORDING TO THE INFORMATION RECEIVED FROM THE SIEMENS HEALTHINEERS CUSTOMER SERVICE ENGINEER (CSE), THE HELIUM COMPRESSOR STOPPED WORKING AND THE HOSPITAL TECHNICIAN REQUESTED A THIRD-PARTY COMPANY TO REPAIR THE SYSTEM. SOME HOURS AFTER THE THIRD-PARTY COMPANY VISITED THE SITE, THE SYSTEM QUENCHED. THE EXACT CIRCUMSTANCES ARE STILL UNDER INVESTIGATION. ALTHOUGH THERE WERE NO INJURIES ASSOCIATED WITH THIS ISSUE, SERIOUS INJURY CANNOT BE EXCLUDED IN THE CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575848 ↗
• InjuryMar 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A SERIOUS INJURY OCCURRED AFTER USING THE MAGNETOM SKYRA (DE). IT WAS STATED THAT A PATIENT REPORTED A TINGLING SENSATION AFTER AN MR EXAMINATION OF THE WRIST JOINT. THE PATIENT SUBSEQUENTLY SAW ANOTHER DERMATOLOGIST AND WAS DIAGNOSED WITH AN ELECTRIC SHOCK INJURY DUE TO REDNESS UNDER THE EPIDERMIS, ALTHOUGH IT WAS NOT RED IN APPEARANCE. TEN DAYS LATER, SHE STILL SEEMED TO HAVE A TINGLING SENSATION ALL OVER HER BODY, MAINLY ON HER BACK. NO FURTHER INFORMATION HAS BEEN PROVIDED ABOUT THE PATIENT'S CURRENT STATE OF HEALTH. THE EXTENT OF THE DESCRIBED INJURIES IS NOT CLEAR. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: Electric Shock

  MAUDE report 21592107 ↗
• InjuryAug 23, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM SKYRA MR SYSTEM. IT WAS REPORTED THAT A PATIENT COMPLAINED OF HEARING LOSS AFTER A SCAN. THE PATIENT HAD AN AUDIOGRAM SOON AFTER THE EVENT, HOWEVER, NO FURTHER INFORMATION ABOUT THE PATIENT'S HEALTH STATUS HAS BEEN RECEIVED. THEREFORE, AN IN-DOUBT REPORTING WILL BE PERFORMED.

  Patient problems: Hearing Impairment; Partial Hearing Loss

  MAUDE report 20046025 ↗
• InjuryAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE REPORTED BY THE SIEMENS HEALTHINEERS CUSTOMER SERVICE ENGINEER (CSE) WHO WAS PERFORMING PREVENTATIVE MAINTENANCE OF THE MAGNETOM SKYRA (DE) SYSTEM. WHILE PERFORMING THE PATIENT TABLE HORIZONTAL DRIVE CHECK FROM THE BOTTOM OF THE TABLE, AND WHILE REACHING UP INTO THE MECHANISM, THE CSE FELT A SHARP PAIN IN HIS NECK. THE CSE DESCRIBED THE PAIN AS EXTENDING FROM HIS NECK DOWN HIS BACK AND TO WHAT FELT LIKE THE BACK OF HIS HEART. INITIALLY, SIEMENS HEALTHINEERS WAS INFORMED THAT THE CSE WAS TREATED WITH PHYSICAL THERAPY; HOWEVER, NEW INFORMATION WAS PROVIDED ON JULY 24, 2024, THAT STATED THE CSE UNDERWENT SURGERY. THE NATURE AND EXTENT OF THE CSE'S INJURY AND TYPE OF SURGICAL PROCEDURE PERFORMED ARE UNKNOWN AS OF THE DATE OF THIS REPORT. IT WAS STATED THAT THE CSE IS ALREADY FEELING MUCH BETTER THREE WEEKS POST-SURGERY. AS OF THE DATE OF THIS REPORT, THE EVENT REPORTED IS SEEN AS A WORK ERROR AND WE CURRENTLY HAVE NO INDICATION OF A PRODUCT MALFUNCTION. THE INVESTIGATION IS ONGOING.

  Patient problems: Neck Pain

  MAUDE report 20046006 ↗
• InjuryMar 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ***ADDITIONAL INFORMATION*** THE PATIENT WENT TO A CHIROPRACTOR, HAD X-RAYS, AND HER DOCTOR STATED THAT HER NECK WAS MISALIGNED. THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE PATIENT'S STATE OF HEALTH, NOR DOES HE KNOW WHETHER MEDICAL TREATMENT OR INTERVENTION WAS NECESSARY AFTER THE X-RAY EXAMINATION.

  Patient problems: Insufficient Information; Unspecified Musculoskeletal problem

  MAUDE report 18941575 ↗
• InjuryMay 15, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT ON (B)(6) 2023, THE DOCKABLE PATIENT TABLE WAS DRIFTING TO THE RIGHT DURING MOVEMENT. IT WAS STATED THAT A TECHNOLOGIST FROM THE HOSPITAL HURT THEIR SHOULDER TRYING THE RESIST AGAINST THE PULLING OF THE DOCKABLE PATIENT TABLE, WITHOUT SPECIFYING THE SEVERITY OF THE INJURY. SIEMENS HEALTHINEERS REQUESTED ADDITIONAL INFORMATION REGARDING THE NATURE AND EXTENT OF THE TECHNOLOGIST INJURY, BUT ADDITIONAL INFORMATION WAS NOT RECEIVED AT THAT TIME AND THE COMPLAINT WAS INITIALLY DEEMED NOT REPORTABLE. PER THE ADDITIONAL INFORMATION RECEIVED BY SIEMENS HEALTHINEERS ON (B)(6) 2023, IT WAS STATED THAT THE CUSTOMER WAS NOT VERY FORTHCOMING REGARDING THE INJURY TO THE TECHNOLOGIST. IT WAS CLARIFIED THAT INJURED TECHNOLOGIST WILL NOT BE ABLE TO RETURN TO WORK IMMEDIATELY. HOWEVER, SIEMENS HEALTHINEERS WAS NOT GIVEN ANY INFORMATION REGARDING A DIAGNOSIS, THE SEVERITY OF THE INJURY OR MEDICAL INTERVENTION. SIEMENS HEALTHINEERS IS THUS REPORTING THIS INCIDENT DUE TO THE TECHNOLOGIST'S INJURY, SINCE BASED ON THE AVAILABLE INFORMATION, WAS SEVERE ENOUGH TO PREVENT THE TECHNOLOGIST FROM WORKING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16930269 ↗
• InjuryJan 25, 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 WHILE OPERATING THE MAGNETOM SKYRA SYSTEM. IT WAS REPORTED THAT A PATIENT SUFFERED A SECOND DEGREE BURN APPROXIMATELY 7 CM IN DIAMETER DURING A PELVIC EXAMINATION. THE BURN WAS FIRST TREATED WITH DEBRIDEMENT FOLLOWED BY MEDICATION. NO OTHER INFORMATION WAS PROVIDED BY THE HOSPITAL AT THE TIME OF THIS REPORT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 13341936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111242, K123510, K130885, K133435, K140253, K141977, K142515, K153343, K163312, K173592, K202014, K231560. One submission often covers many models, so check the product and lot details in each record.

• Z-2658-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Lumina (DE). Model Number: 11344916.
• Z-2661-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra fit. Model Number: 10849580.
• Z-2667-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
• Z-2659-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2343-2019 · Jul 9, 2019 · Terminated
  MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
• Z-2342-2019 · Jul 9, 2019 · Terminated
  MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
• Z-0467-2016 · Dec 7, 2015 · Terminated
  MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
• Z-1663-2014 · Apr 24, 2014 · Terminated
  MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional