Somatom On.site 11605361Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869973180), received between Feb 13, 2026 and Feb 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).

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.

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.

• MalfunctionFeb 13, 2026Image Display Error/Artifact

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM ON.SITE CT SYSTEM. BASED ON THE INFORMATION AVAILABLE, ARTIFACTS WERE PRESENT IN THE SCAN OF A 2-YEAR-OLD EMERGENCY PATIENT. AS A RESULT, THE SCAN WAS REPEATED, BUT THE IMAGE ARTIFACTS PERSISTED. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN THE DAYS FOLLOWING THE EXAMINATION; HOWEVER, THE CHILD'S DEATH WAS NOT RELATED TO THE REPORTED ISSUE REGARDING THE MEDICAL DEVICE. ADDITIONAL INFORMATION ON THE CIRCUMSTANCES OF THE PATIENT¿S DEATH WAS REQUESTED FROM THE USER FACILITY, BUT NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330922 ↗