SOMATOM On.site 11369300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869263045), received between Jan 25, 2021 and Jan 25, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Poor Quality Image” (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 16, 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.

• DeathJan 25, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO SIEMENS BY THE CUSTOMER USE TEST (CUT) SITE THAT A MALFUNCTION OCCURRED WHILE USING THE SOMATOM ON.SITE SYSTEM. DURING THE EVENING OF JANUARY 13, 2021, A PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT OF ERASMUS MC. THE PATIENT HAD SUFFERED AN OUT OF HOSPITAL CARDIAC ARREST (OHCA) AND WAS IN POOR CONDITION UPON ARRIVAL. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE FACILITY INTENSIVE CARE UNIT (ICU) WITHOUT WAITING FOR IMAGING TO BE PERFORMED. LATER THAT SAME EVENING, A REQUEST WAS MADE TO RADIOLOGY TO PERFORM CT BRAIN IMAGING USING THE SOMATOM ON.SITE MOBILE CT (AVAILABLE IN ERASMUS MC AS A PROTOTYPE IN A CUT PHASE) TO AVOID TRANSPORTING THE PATIENT, WHO WAS IN A FRAGILE MEDICAL STATE, TO THE RADIOLOGY DEPARTMENT FOR IMAGING USING A STATIONARY CT SCANNER. THE INDICATION FOR BRAIN IMAGING WAS TO RULE OUT INTRACRANIAL HEMORRHAGE. AN EXPERIENCED CT RADIOGRAPHER WAS AVAILABLE, SO THE ICU AGREED TO THE PERFORMANCE OF THE CT SCAN USING THE REPORTED MOBILE CT. IT WAS ALSO REPORTED THAT THE ICU WAS VERY BUSY DURING THE EVENING OF THE REPORTED EVENT, SO THE STAFF WAS PRESSURED FOR TIME. DURING THE PREPARATION OF THE SCAN, THE RADIOGRAPHER ENCOUNTERED A PROBLEM WITH TH

  Patient problems: Cardiac Arrest

  MAUDE report 11222680 ↗