MAGNETOM Altea 11410371Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869230726), received between Aug 23, 2024 and Jan 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Defective Component; Defective Component

  IT WAS REPORTED TO SIEMENS THAT AN ISSUE WAS DISCOVERED ON THE MAGNETOM ALTEA (CN). IT WAS STATED THAT THE CUSTOMER FOUND THE LOWER PART OF THE BM HEAD/NECK 20 COIL SURFACE HAD BEEN BURNED WITH A HOLE AND THE DIAMETER WAS ABOUT 10 MM. THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21156537 ↗
• InjuryAug 23, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM ALTEA MR SYSTEM. IT WAS STATED THAT A PATIENT REPORTED A SKIN BURN SEVEN DAYS AFTER AN MR SCAN. THE PATIENT NOTED PAIN AND BLISTERS ON THE INDEX KNUCKLE AND LEFT FOREARM WHEN HE GOT IN THE CAR AFTERWARDS. LATER IT WAS DIAGNOSED THAT THE PATIENT SUFFERED A FULL THICKNESS BURN ON THE LEFT FOREARM AND A PARTIAL THICKNESS BURN ON THE RIGHT INDEX KNUCKLE. BOTH BURNS HAVE A SIZE LIKE A KNUCKLE. IT WAS STATED THAT THE POINTS OF BURN WERE TOUCHING EACH OTHER DURING EXAMINATION.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 20046046 ↗