MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM X.CITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthineers is currently conducting a comprehensive investigation into the reported event.As the investigation is ongoing, the root cause has not yet been identified.A supplemental report will be provided as soon as additional information becomes available.
Event or Problem Description
On november 24, 2025, siemens healthineers was notified of a technical issue involving a somatom x.Cite ct system located in the united states.The customer reported that the system¿s patient table was ¿moving on its own without any buttons being pressed.¿ at this time, there have been no reports of adverse health effects related to this issue.We are submitting this report out of an abundance of caution.
Additional Manufacturer Narrative
Siemens has not yet completed the investigation of the reported event.As this event is still under investigation, the root cause has not yet been determined.A supplemental report will be submitted as soon as additional relevant information becomes available.A final report will be provided upon completion of the investigation.

• Brand Name: SOMATOM X.CITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 - or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 23744101
• Report Number: 3004977335-2025-00141
• Device Sequence Number: 15662250
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: (01)04056869231044
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K233650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11330001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 06/01/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/30/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown