MAGNETOM Sempra 10840815Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869044521), received between Oct 12, 2021 and Oct 12, 2021 — classified as 1 malfunction.

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 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021Adverse 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 SEMPRA SYSTEM. DURING A PELVIS SCAN, A (B)(6) YEAR OLD FEMALE PATIENT HAD DIFFICULTY BREATHING. THE PATIENT ALERTED THE OPERATOR AND THE SCAN WAS STOPPED. THE PATIENT WAS PROVIDED OXYGEN BUT WAS STILL HAVING DIFFICULTY BREATHING AND COLLAPSED AND BECAME UNCONSCIOUS. THE PATIENT WAS TRANSFERRED TO THE CARDIAC ICU FOR FURTHER MANAGEMENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 12613760 ↗