MAGNETOM SkyraRecalls & reported problems across all models

We found 2 models of MAGNETOM Skyra by Siemens Healthcare GmbH in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2022 and Apr 13, 2026 — classified as 9 injuries, 1 malfunction.

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

3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MAGNETOM Skyra recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 28, 2025Open, 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. Aug 28, 2025Open, 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 ↗

3. Sep 1, 2023Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported MAGNETOM Skyra problems

MAGNETOM Skyra models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MAGNETOM Skyra 10432915

  System, nuclear magnetic resonance imaging
  2 recalls8 reports
• MAGNETOM Skyra 10849580

  Coil, magnetic resonance, specialty
  2 recalls2 reports

Recent MAGNETOM Skyra adverse event reports

The 10 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Siemens Healthcare GmbH products

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• MAGNETOM Vida2 models · 12 reports · 2 recalls
• MAGNETOM Lumina2 models · 3 reports · 2 recalls
• MAGNETOM Prisma2 models · 2 reports · 2 recalls
• MAGNETOM Sola2 models · 16 reports · 1 recall
• Cios Alpha2 models · 15 reports · 1 recall