MAGNETOM Sola 11291455Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04056869164809), received between Jul 7, 2020 and Sep 23, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

1 FDA recall record name this device's identifier, 1 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Insufficient Device Problem Information

  Siemens Healthineers (Siemens) was notified of a patient health event associated with an examination performed using a MAGNETOM Sola MRI system. According to the customer, the patient had a known history of allergies to latex and perfumes/fragrances.Shortly after the examination, the patient developed tingling and itching of the hands, which progressed to generalized pruritus and worsening symptoms. Subsequently, the patient experienced widespread raised skin lesions and significant respiratory difficulty. The patient sought treatment at an Urgent Care facility, where she received adrenaline, hydrocortisone (100 mg), and chlorphenamine.The patient reported that she was formally diagnosed with anaphylaxis following the event and was subsequently prescribed an EpiPen. The symptoms resolved within approximately one hour, and the patient made a full recovery. Due to the severity of the reaction and the requirement for emergency medical intervention, this event is considered reportable.

  Patient problems: Anaphylactic Shock

  MAUDE report 50866824 ↗
• InjuryApr 24, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A SERIOUS INJURY ASSOCIATED WITH A MAGNETOM SOLA SYSTEM. IT WAS COMMUNICATED THAT DURING AN MR BRAIN EXAMINATION, THE PATIENT WAS INJURED AS THE TABLE WAS EXITING THE BORE. THE TECHNOLOGIST STATED THAT THE PATIENT SUSTAINED A HUMERAL FRACTURE WHILE THE TABLE WAS BEING MOVED OUT OF THE BORE. FACILITY PHYSICIANS WERE REQUIRED TO INTERVENE, AND THE PATIENT MUST UNDERGO SURGICAL TREATMENT FOR THE FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 24981455 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL INJURY ASSOCIATED WITH THE MAGNETOM SOLA SYSTEM. IT WAS COMMUNICATED THAT A PATIENT HAD A BURN ON THE UNDERSIDE OF THE BREAST. ALTHOUGH REQUESTED, DETAILED INFORMATION REGARDING THE SEVERITY OF THE INJURY, MEDICAL INTERVENTION PROVIDED, AND CURRENT HEALTH STATUS OF THE PATIENT HAVE NOT BEEN PROVIDED TO SIEMENS HEALTHINEERS AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 24730707 ↗
• MalfunctionNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM SOLA SYSTEM. IT WAS STATED THAT A PATIENT WAS BURNT DURING AN MR EXAMINATION WITH A KNEE COIL. ADDITIONAL INFORMATION ABOUT THE SEVERITY OF THE BURN AND MEDICAL TREATMENT PROVIDED HAS BEEN REQUESTED BY SIEMENS HEALTHINEERS BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 23568192 ↗
• InjuryNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM SOLA SYSTEM. IT WAS STATED THAT AFTER POSITIONING THE PATIENT ON THE TABLE THE OPERATOR SCHEDULED ACQUISITIONS FOR THE EXECUTION OF THE SEQUENCE. ON THE SPEAKER OF SCANNER, THE PATIENT HEARD THAT THE TABLE WOULD MOVE AGAIN FOR CENTERING OF CERVICAL AREA. AS THE TABLE STARTS MOVING, THE PATIENT SCREAMS IN PAIN AND PRESSES THE SQUEEZE BALL. THE PATIENT'S ARM WAS STUCK BETWEEN THE BORE AND THE TABLE. PER THE COMPLAINT REPORT A CT SCAN CONFIRMED A FRACTURE OF THE HUMERAL HEAD, WHICH REQUIRES SURGICAL INTERVENTION.

  Patient problems: Limb Fracture

  MAUDE report 23495897 ↗
• MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL PATIENT INJURY INVOLVING THE MAGNETOM SOLA. PER THE RECEIVED INFORMATION FROM THE CUSTOMER, THE PATIENT WAS BURNED DURING AN EXAMINATION. ALTHOUGH REQUESTED, NO INFORMATION HAS BEEN RECEIVED BY SIEMENS HEALTHINEERS REGARDING ADDITIONAL EVENT DETAILS, EXTENT OF THE PATIENT¿S BURN(S), AND ANY MEDICAL TREATMENT THAT MAY HAVE BEEN PROVIDED. THE ADDITIONAL INFORMATION IS PENDING RECEIPT AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 23310064 ↗
• MalfunctionMay 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE CONCERNING THE MAGNETOM SOLA SYSTEM. IT WAS STATED IN THE COMPLAINT THAT THE SYSTEM MAGNET QUENCHED AFTER THE REPLACEMENT OF THE COLDHEAD BYPASS. THE MAGNET QUENCHED WITH A LOT OF ICE IN THE TURRET. IN THIS SITUATION THE AUXILIARY BURST DISK SHOULD BREAK, BUT FORTUNATELY IT DID NOT. AFTER OPENING THE TOP PLATE, IT WAS OBSERVED THAT THE AUXILIARY VENT TUBE WAS BLOCKED WITH ICE AS WELL. NO ONE WAS INJURED BECAUSE THE VESSEL STAYED INTACT. IN A WORST-CASE SCENARIO, SINCE BOTH THE TURRET AND THE AUXILIARY VENT HAD BEEN COMPLETELY BLOCKED WITH ICE, THE QUENCH COULD HAVE LED TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026638 ↗
• MalfunctionFeb 7, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE USING THE MAGNETOM SOLA. THE USER REPORTED THAT THE TABLETOP MOVED BY ITSELF TOWARDS THE MAGNET AFTER THE TABLE WAS UNDOCKED AND 2 FEET AWAY FROM THE MAGNET. THERE WAS A 350 LB. PATIENT ON THE TABLE. THE CUSTOMER HEARD A SOUND LIKE A MOTOR REVOLVING AT THE TIME. THE EMERGENCY RELEASE HANDLE WAS NOT PULLED. THE CUSTOMER PRESSED THE TABLE STOP BUTTON TO STOP THE TABLETOP MOVEMENT. OUR EXPERTS INVESTIGATED THE ISSUE AND RECREATED THE DESCRIBED SITUATION. A TEST WITH A 250 KG DUMMY SHOWED THAT IF THE TABLETOP IS MOVED OUT BY ABOUT 1.01 M, THE TABLE TIPS OVER. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331510 ↗
• InjuryJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL SERIOUS INJURY ASSOCIATED WITH THE MAGNETOM SOLA SYSTEM. ACCORDING TO THE RECEIVED INFORMATION, A PATIENT WAS SUSTAINED A SECOND DEGREE BURN DURING AN MRI EXAMINATION OF THE LEGS. IT WAS STATED THAT MEDICAL TREATMENT WAS NECESSARY; HOWEVER, THE TYPE OF TREATMENT WAS NOT REPORTED TO SIEMENS HEALTHINEERS. THE FACILITY PROVIDED A PICTURE OF THE PATIENT¿S BURN, AND IT WAS REVIEWED BY A SIEMENS HEALTHINEERS MEDICAL OFFICER. THE MEDICAL OFFICER STATED THAT THE BURN APPEARED TO HAVE BEEN GRADE 2B AND MEDICAL INTERVENTION COULD HAVE BEEN NECESSARY. ADDITIONAL INFORMATION REGARDING THE PROVIDED MEDICAL INTERVENTION AND THE CURRENT HEALTH STATUS OF THE PATIENT HAS BEEN REQUESTED AND IS PENDING RECEIPT BY SIEMENS HEALTHINEERS.

  Patient problems: Burn(s)

  MAUDE report 19457894 ↗
• InjuryMay 19, 2023Device Handling Problem; Noise, Audible; Device Handling Problem; Noise, Audible

  PER THE COMPLAINT REPORT, RECEIVED BY SIEMENS HEALTHINEERS ON 2023-05-16, IT WAS STATED THAT PATIENT HAD TINNITUS BEFORE THE MRI EXAMINATION ON (B)(6) 2021 AND HE CLAIMED THAT THE MRI EXAMINATION MADE THE TINNITUS WORSE. IN ADDITION, THE PATIENT IS COMPLAINING THAT THE TINNITUS IS CAUSING OTHER MENTAL HEALTH ISSUES. THIS EVENT REFLECTS A PERMANENT HEALTH IMPACT AND SERIOUS INJURY. PER THE COMPLAINT REPORT SIEMENS HEALTHINEERS RECEIVED THE FOLLOWING INFORMATION: PATIENT WAS WEARING EARPLUGS AND HEADPHONES AT THE BEGINNING OF THE EXAMINATION PATIENT REMOVED HEADPHONES HIMSELF AFTER HEARING "SCREECH" NOISE THROUGH THE HEADPHONES PATIENT DID NOT PRESS THE SQUEEZE BALL DURING EXAMINATION PATIENT HAS BEEN SEEN BY HOSPITAL CONSULTANTS WHO WERE UNABLE TO FIND ANY ISSUES ACCORDING TO A REVIEW OF THE COMPLAINT HANDLING SYSTEM, NO FURTHER SIMILAR INCIDENTS OCCURRED WITH THIS SYSTEM SINCE THIS INCIDENT ON (B)(6) 2021. THE ISSUE OCCURRED OVER TWO YEARS AGO. COMPLAINANT STATED THAT SAVE LOG, DICOM IMAGES, SYSTEM QA, QA OF THE AFFECTED COIL OF THE TIME OF THE INCIDENT ARE NOT AVAILABLE FOR AN ADEQUATE PROBLEM INVESTIGATION. INFORMATION REGARDING PATIENT HEALTH STATUS, SYSTEM HISTORY AND ADDITIONA

  Patient problems: Tinnitus; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 16962868 ↗
• InjuryAug 10, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT A 13-YEAR-OLD PATIENT FELT A BURNING SENSATION AND PAIN AFTER SEVERAL HOURS FOLLOWING AN MR EXAMINATION OF THE PATIENT'S ELBOW ON (B)(6) 2022. SIEMENS HEALTHINEERS CONDUCTED A DETAILED INVESTIGATION OF THE INCIDENT AND BASED ON THE THEN AVAILABLE INFORMATION AND CONCLUDED THAT NO THERE WAS NO INDICATION OF SERIOUS INJURY OR SYSTEM MALFUNCTION. THEREFORE, THIS ISSUE WAS INITIALLY CLASSIFIED AS NOT SAFETY RELEVANT. SUBSEQUENTLY, ON (B)(6) 2022, ADDITIONAL INFORMATION WAS PROVIDED TO SIEMENS HEALTHINEERS ABOUT THE PATIENT'S INJURY. SIEMENS HEALTHINEERS WAS INFORMED THAT PATIENT'S LATERAL RIGHT THIGH AND A RECTANGULAR SHAPED AREA UNDER THE RIGHT SHOULDER BLADE, APPROXIMATELY 2-3 INCHES FROM THE MID-BACK, WERE BLISTERED BECAUSE OF THE MRI IMAGING. THE PATIENT WAS TREATED AT HOME. PROFESSIONAL MEDICAL TREATMENT WAS NOT SOUGHT.

  Patient problems: Blister; Bruise/Contusion; Pain; Superficial (First Degree) Burn

  MAUDE report 15198429 ↗
• MalfunctionOct 22, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE MAGNETOM SOLA SYSTEM. DURING A CARDIAC STUDY, THE USER REPORTED THAT THE SYSTEM HUNG UP, AND THE STUDY HAD TO BE REPEATED. IT IS NOT KNOWN IF ADDITIONAL CONTRAST WAS ADMINISTERED. AT THIS TIME, WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10717390 ↗
• MalfunctionJul 7, 2020Use of Device Problem; Use of Device Problem

  SIEMENS WAS NOTIFIED ABOUT AN INCIDENT THAT OCCURRED ON THE MAGNETOM SOLA SYSTEM. PATIENT WAS POSITIONED HEADFIRST ON THE TABLE AND COMPLETED HER CERVICAL AND THORACIC SPINE STUDIES. AS THE PATIENT WAS BEING REMOVED FROM THE BORE OF THE MRI MACHINE, THE PATIENT SCREAMED. THE PATIENT INFORMED THE TECHNOLOGIST THAT HER SHOULDER HURT. THE PATIENT WAS THEN PLACED IN THE WHEELCHAIR AND LEFT THE FACILITY. LATER THE PATIENT HAD FOLLOW-UP X-RAYS THAT SHOWED SHE HAD AN IMPACTED HUMERUS FRACTURE. SIEMENS WAS NOT PROVIDED DETAILS OF THE AFTERCARE OF THE PATIENT ONCE SHE LEFT THE MEDICAL FACILITY.

  Patient problems: Bone Fracture(s); Patient Problem/Medical Problem

  MAUDE report 10240652 ↗