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SOMATOM X.cite 11330001 (UDI 04068151994995)Recalls & reported problems

Siemens Healthineers AG · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04068151994995), received between May 7, 2026 and May 13, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem1
  • Radiation Overexposure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 13, 2026Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SCANNER. ON (B)(6) 2026, A STROKE PATIENT WAS SCHEDULED FOR A CT SCAN; HOWEVER, THE EXAMINATION COULD NOT BE PERFORMED AS THE SYSTEM¿S PATIENT HANDLING SYSTEM (PHS) FUNCTIONALITY DID NOT WORK. AS A RESULT, THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER CT SYSTEM IN ORDER TO COMPLETE THE SCAN, LEADING TO A DELAY OF APPROXIMATELY 15 MINUTES. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT DID NOT EXPERIENCE ANY KNOWN NEGATIVE HEALTH CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25161381 ↗
  • MalfunctionMay 7, 2026Radiation Overexposure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SCANNER. REPORTEDLY, A TRAUMA CT HEAD EXAMINATION COULD NOT BE COMPLETED AS INTENDED ON THE SYSTEM. AFTER ACQUISITION OF THE TOPOGRAM, THE SCAN WAS ABORTED BY THE CUSTOMER DUE TO REPORTED SYSTEM-RELATED ERRORS. THE PATIENT WAS TRANSFERRED TO ANOTHER CT SYSTEM, WHERE THE EXAMINATION WAS COMPLETED. AS A RESULT, THE EXAMINATION WAS DELAYED BY APPROXIMATELY 15 MINUTES. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25111349 ↗

Other System, x-ray, tomography, computed devices

All System, x-ray, tomography, computed devices →

Sources and updates

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