SOMATOM Emotion 16 Slice (DE) 10046789Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869013114), received between Jan 13, 2022 and Aug 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K050297); 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM EMOTION 16 CT SYSTEM. THE CUSTOMER REPORTED THAT THE HEAD HOLDER ON THE PATIENT TABLE DETACHED DURING A PATIENT POSITIONING PROCEDURE. THERE WAS NO IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715189 ↗
• MalfunctionJan 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO SIEMENS THAT THE GANTRY DRIVE BELT OF THE SOMATOM EMOTION 16 SYSTEM WAS BROKEN DURING A PATIENT SCAN. THE TORN BELT CRASHED THROUGH THE COVER OF THE CT SCANNER SCAN WINDOW AND HIT THE PATIENT'S LEGS. THERE WAS NO REPORTED PATIENT INJURY; HOWEVER, IN A WORST-CASE SCENARIO, PATIENT INJURY CANNOT BE EXCLUDED IF THE EVENT WERE TO REOCCUR. THE REPORTED EVENT OCCURRED IN THE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050297. One submission often covers many models, so check the product and lot details in each record.

• Z-1452-2018 · Feb 15, 2018 · Terminated
  SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
• Z-1459-2018 · Feb 15, 2018 · Terminated
  SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
• Z-1453-2018 · Feb 15, 2018 · Terminated
  SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
• Z-1454-2018 · Feb 15, 2018 · Terminated
  SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
• Z-1301-2016 · Feb 15, 2016 · Terminated
  Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission
• Z-1721-2014 · Mar 21, 2014 · Terminated
  Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of
• Z-2453-2008 · Aug 5, 2008 · Terminated
  SOMATOM Emotion 16. Computed tomography X-ray system
• Z-0793-06 · Mar 9, 2006 · Terminated
  SOMATOM CT System Emotion 16. Computed tomography x-ray system.