Somatom Perspective (DE) 10046734Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869013046), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Output Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K133590); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• DeathAug 24, 2020Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT DURING AN EMERGENCY EXAMINATION USING THE SOMATOM PERSPECTIVE 16 SYSTEM, THE SCANNING PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT DIED ON THE CT-TABLE. ACCORDING TO THE HEAD OF THE FACILITY EMERGENCY DEPARTMENT, THE PATIENT HAD THROWN HIMSELF OUT OF A WINDOW AND FELL APPROXIMATELY THREE METERS BEFORE HE WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS UNCONSCIOUS, BUT HIS VITAL PARAMETERS WERE STABLE UPON HOSPITAL EMERGENCY ROOM ADMISSION. AFTER THE PATIENT WAS POSITIONED ON THE CT-TABLE, THE HEALTH STATUS OF THE PATIENT DETERIORATED, AND THE PATIENT WAS INTUBATED. SUBSEQUENTLY, A CIRCULATORY FAILURE OCCURRED, AND NO FURTHER RESUSCITATION WAS PERFORMED DUE TO THE PATIENT'S MEDICAL HISTORY (PREEXISTING UNSPECIFIED LUNG AND MYOCARDIAL CONDITIONS). THE HEAD OF THE EMERGENCY DEPARTMENT STATED THAT THE PATIENT'S PROGNOSIS WAS RATHER POOR UPON ADMISSION. IT IS NOT KNOWN IF THE SYSTEM ISSUE, THAT RESULTED IN A DELAY IN DIAGNOSIS, ATTRIBUTED TO THE PATIENT'S DEATH. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Death

  MAUDE report 10441580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133590. One submission often covers many models, so check the product and lot details in each record.

• Z-1646-2015 · Apr 20, 2015 · Terminated
  SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the