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
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
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- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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