SOMATOM Emotion 16-slice configuration 10165977Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869010304), received between Nov 30, 2020 and Sep 5, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K050297, K140232, K183548); 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.

• InjurySep 5, 2025Use of Device Problem; Use of Device Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE SOMATOM EMOTION CT-SCANNER. A MOBILITY IMPAIRED PATIENT (CEREBRAL HEMORRHAGE) INJURED HER WRIST DURING A CT SCAN. THE OPERATOR DID NOT USE THE RETRAINING STRAPS ON THE PATIENT AS STATED IN THE INSTRUCTIONS FOR USE. THE PATIENT¿S HAND DROPPED DOWN WHEN THE PHS (PATIENT HANDLING SYSTEM) MOVED OUT FROM THE GANTRY, RESULTING IN HER WRIST BONE TO BREAK. THE PATIENT WAS TREATED WITH A BANDAGE AND FIXATION AT THE MEDICAL FACILITY. CURRENT STATUS OF THE PATIENT IS NOT KNOWN. SIEMENS REQUESTED ADDITIONAL INFORMATION, HOWEVER, THE CUSTOMER COULD NOT PROVIDE MORE SPECIFIC INFORMATION.

  Patient problems: Limb Fracture

  MAUDE report 22975895 ↗
• InjuryNov 30, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED TO SIEMENS THAT DURING A CT SCAN USING THE REPORTED SOMATOM EMOTION SYSTEM, THE PATIENT'S LEG WAS FRACTURED WHEN HER KNEE COLLIDED WITH THE GANTRY ALTHOUGH SHE WAS STATIONARY AT THE TIME. DURING THE SCAN, THE PATIENT WAS UNCONSCIOUS, AND HER LEG COULD NOT BE PROPERLY STRETCHED AS SHE WAS POSITIONED ON THE PATIENT TABLE. HER LEG WAS BENT TOWARD HER ABDOMEN. DURING THE PROCEDURE THE PATIENT'S FAMILY WAS IN THE CT ROOM AND BLOCKED THE TECHNICIAN'S LINE OF SIGHT, RESULTING IN THE TECHNICIAN NOT BEING ABLE TO OBSERVE THE PATIENT PROPERLY AND THE STOP THE TABLE MOVEMENT TO PREVENT THE COLLISION. THE PATIENT WAS TREATED AT THE HOSPITAL FOR THE LEG FRACTURE. THE REPORTED EVENT OCCURRED IN THE (B)(6).

  Patient problems: Limb Fracture

  MAUDE report 10919296 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050297, K140232, K183548. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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.