MAGNETOM Sola 11410231Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869217864), received between Jan 24, 2024 and Aug 26, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Wireless Communication Problem

  Siemens Healthineers (Siemens) was notified of an operator injury associated with the MAGNETOM Sola system. The reported event indicated that the operator went into the examination room to test how loud the voice instructions were through the headphones. The operator stated that the volume was so loud that it caused acoustic shock and the feeling of a blocked ear. After the system was rebooted, the sound volume returned to normal. Based on additional information received by Siemens on August 21, 2026, the operator was treated with steroids. This indicates tinnitus therapy and is considered medical intervention to prevent potential permanent hearing damage or persistent tinnitus.

  Patient problems: Acoustic Shock

  MAUDE report 50454977 ↗
• InjuryJul 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL PATIENT INJURY AFTER A FEMORAL MRI EXAMINATION USING THE MAGNETOM SOLA SYSTEM. THE PATIENT REPORTED WHOLE BODY WARMTH DURING THEIR SCAN WHEN A TECHNICIAN WENT IN TO ADMINISTER CONTRAST AGENT. LATER THAT DAY, SKIN REDNESS WAS NOTED IN THE GROIN AREA AND A 2 MM BLACK SPOT ON THE OPPOSITE THIGH WAS FOUND. THE INJURIES WERE NOTICED IN THE WARD WHERE THE PATIENT WAS TREATED FOR VARIOUS PRE-EXISTING CONDITIONS AS AN INPATIENT. THE PATIENT'S PRE-EXISTING CONDITIONS WERE DESCRIBED AS THE FOLLOWING: EXTENSIVE PELVIC FIXATION FROM REMOVAL OF OSTEOSARCOMA, PREVIOUS HEMIPELVECTOMY AND SACRUM REMOVAL AND EXTENSIVE FIXATIONS IN THE LUMBAR SPINE. FURTHERMORE, THE PATIENT HAD A RECENT TRAUMATIC FALL RESULTING IN MULTIPLE PROCEDURES AND DEBRIDEMENT. THE AREA OF OR NEAR THE REDNESS WAS COVERED IN A BANDAGE FROM A PREVIOUS DEBRIDEMENT DURING THE MRI EXAMINATION. THE PATIENT STATED THAT THE BLACK SPOT WAS NOT THERE PRIOR TO THE MRI. THE REDNESS WAS TREATED WITH A COLD COMPRESS AND FLAMAZINE CREAM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE, AND IF ANY TREATMENT WAS NECESSARY FOR THE BLACK SPOT. THE INJURY IS STILL RESOLVING. THE PATIENT DECLINED PICTU

  Patient problems: Burn(s)

  MAUDE report 22586184 ↗
• MalfunctionJan 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED THAT A PATIENT SUSTAINED AN INJURY OF UNKNOWN SEVERITY DURING A HAMSTRING ATTACHMENT BILATERAL MRI EXAMINATION WITH THE MAGENETOM SOLA SYSTEM. SIEMENS HEALTHINEERS WAS INFORMED THAT THE PATIENT HAD REDNESS ON HIS LOWER BACK AND AN APPROXIMATELY 2CM BURN ON HIS PENIS. THE SEVERITY OF THE BURN IS UNKNOWN TO SIEMENS HEALTHINEERS AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER FACILITY REGARDING THE EVENT, EXTENT OF THE PATIENT¿S INJURY, AND ANY MEDICAL TREATMENT PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 18570131 ↗