MAGNETOM Altea 11344915Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056869230719), received between Apr 28, 2022 and Sep 8, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Improper or Incorrect Procedure or Method

  Siemens Healthineers (Siemens) was notified of a potential patient injury associated with a MAGNETOM Altea MRI system. According to the report, the patient complained of hearing issues following an MRI examination on (b)(6)2026. The patient wore only headphones during the scan and did not use the combination of headphones and earplugs specified for hearing protection. It was confirmed that the hearing protection warning signage was posted on the examination room door. The patient was evaluated by an ENT specialist on (b)(6)2026. Based on additional information received on September 2, 2026, Siemens was informed by the customer that the patient was diagnosed with Stage 2 temporomandibular joint (TMJ) disorder. The customer indicated that no additional information is available from the patient's ENT specialist or directly from the patient. The customer also confirmed that the patient did not use the hearing protection prescribed in the system Instructions for Use and wore only the standard Siemens headphones during the examination. As sufficient information is not available to rule out the occurrence of a serious injury, this event is being reported.

  Patient problems: Hearing Impairment

  MAUDE report 50666638 ↗
• InjuryAug 18, 2026Insufficient Device Problem Information

  Siemens Healthineers (Siemens) was notified of a patient injury associated with a MAGNETOM Altea system. The reported event indicated that the patient sustained a radiofrequency burn. The patient was evaluated at an urgent care facility, where antibiotics were prescribed and burn ointment was provided.Additional information about the severity of the burn has been requested, but has not been received to this date.Therefore, in-doubt reporting is performed.

  Patient problems: Burn(s)

  MAUDE report 50299373 ↗
• InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM ALTEA SYSTEM. IT WAS STATED IN THE INITIAL COMPLAINT THAT A PATIENT OBTAINED A BURN DURING AN MR EXAMINATION OF THE HIP. ACCORDING TO THE INFORMATION PROVIDED IN THE QUESTIONNAIRE, THERE WAS AN AREA (10X10 CM IN SIZE) OF SKIN REDNESS AND BURNING SENSATION ON BOTH INNER SIDES OF THE PATIENT¿S LEGS. A CREAM FOR BURNS WAS PRESCRIBED. SIEMENS HEALTHINEERS WAS INFORMED ON (B)(6) 2025 THAT A CRUST HAS FORMED OVER THE BURNED AREA AND THAT IT IS STILL NOT HEALED COMPLETELY. THE SIEMENS HEALTHINEERS MEDICAL OFFICER ASSESSED THE AVAILABLE INFORMATION. THE FORMATION OF A CRUST AND A HEALING TIME OF MORE THAN 12 DAYS SUGGEST THAT THE PATIENT OBTAINED A BURN OF GRADE 2B OR HIGHER.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23451105 ↗
• InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL PATIENT INJURY INVOLVING THE MAGNETOM ALTEA SYSTEM. PER THE INFORMATION RECEIVED FROM THE CUSTOMER IT WAS STATED THAT THE PATIENT WAS PLACED FEET FIRST INTO THE MRI. AFTER THE EXAMINATION, WHEN THE PATIENT WAS REMOVED FROM THE BORE, IT WAS NOTED THAT THE PATIENT HAD BLISTERS ON THE INSIDE OF BOTH THIGHS. MEDICAL TREATMENT WAS PROVIDED, HOWEVER, THE EXTENT OF THE BURNS AND TYPE OF TREATMENT PROVIDED WERE NOT REPORTED TO SIEMENS HEALTHINEERS.

  Patient problems: Burn(s)

  MAUDE report 23450720 ↗
• InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM ALTEA SYSTEM. PER THE RECEIVED INFORMATION, THE PATIENT RECEIVED A 25MM X 25MM BURN ON THE RIGHT SHOULDER DURING AN MRI EXAMINATION USING A THIRD-PARTY ELECTRODE HEART MONITORING DEVICE. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE EVENT AND THE EXTENT OF THE PATIENT¿S INJURY. THE ADDITIONAL INFORMATION IS PENDING RECEIPT AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 22976145 ↗
• InjurySep 4, 2024Accessory Incompatible; Use of Device Problem; Accessory Incompatible; Use of Device Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT INVOLVED THE MAGNETOM ALTEA SYSTEM. AN OXYGEN TANK WAS BROUGHT INSIDE THE MRI EXAMINATION ROOM BY HOSPITAL PERSONNEL. THE TANK WAS PULLED BY THE MRI MACHINE; A DOCTOR¿S LEG WAS PINNED TO THE MACHINE BY AN OXYGEN TANK. THE MRI UNIT QUENCHED. THE DOCTOR REQUIRED A MEDICAL TREATMENT FOLLOWING THE INCIDENT AND NEEDED A SURGERY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.

  Patient problems: Crushing Injury

  MAUDE report 20137272 ↗
• InjuryAug 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  SIEMENS HEALTHINEERS WAS INITIALLY INFORMED ON JULY 27, 2023, THAT A PATIENT SUSTAINED BURNS ON BOTH INNER THIGHS DURING AN MR PROSTATE EXAMINATION ON (B)(6) 2023. INITIALLY, IT WAS STATED THAT THE PATIENT SUSTAINED OVAL BURNS APPROXIMATELY 1.5CM CM LONG ON BOTH INNER THIGHS. THE SEVERITY OF THE BURNS WAS NOT INITIALLY REPORTED TO SIEMENS HEALTHINEERS. THE INITIAL COMPLAINT INFORMATION AND PHOTOS OF THE BURNS WERE ANALYZED BY A SIEMENS HEALTHINEERS MEDICAL OFFICER, WHO CONCLUDED THESE COULD BE THIRD-DEGREE BURNS. ADDITIONAL INFORMATION WAS PROVIDED TO SIEMENS HEALTHINEERS ON JULY 31, 2023, STATING THAT THE PATIENT HAD NOT COMPLAINED OF PAIN OR ALERTED THE MEDICAL TECHNICAL ASSISTANT PRESENT DURING THE EXAMINATION. IT WAS STATED THAT THE MEDICAL TECHNICAL ASSISTANT ROUTINELY WENT INTO THE SCANNING ROOM BEFORE ADMINISTERING THE CONTRAST AGENT AND NOTICED REDDENING OF THE PATIENT¿S SKIN. THE EXAMINATION WAS THEN STOPPED IMMEDIATELY. IT WAS FURTHER REPORTED THAT ALTHOUGH THE REDNESS ON THE INSIDE OF THE PATIENT¿S THIGHS HAS RECEDED, TWO DEEP ROUND THIRD-DEGREE BURNS REMAIN. EACH BURN IS APPROXIMATELY 2.5CM IN SIZE. ACCORDING TO THE DERMATOLOGICAL OUTPATIENT DEPARTMENT OF THE HOSPITAL,

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17452218 ↗
• InjuryApr 28, 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 FOLLOWING EXAMINATION ON THE MAGNETOM ALTEA MR SYSTEM. A PATIENT REPORTED LOUD NOISES DURING A SHOULDER EXAMINATION ON (B)(6) 2002. THE PATIENT ALREADY HAD TINNITUS WHICH WAS AGGRAVATED BY THE MR EXAMINATION. THE PATIENT WAS WEARING HEADPHONES DURING THE EXAMINATION AND IT WAS REPORTED THAT NO OTHER HEARING PROTECTION WAS PROVIDED. AT THIS TIME IT IS UNCLEAR IF THE PATIENTS TINNITUS IS TEMPORARY OR PERMANENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Tinnitus

  MAUDE report 14237249 ↗