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

Model Number	11330001
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom x.Cite ct scanner.During patient positioning for a thorax/abdomen scan, the user reported that while moving the table with a patient on it into the gantry, the table kept moving after having released the ¿move¿ button.Once the table moved to the end-position, the buttons on the left gantry panel became unresponsive.After pressing the emergency stop button and clicking ¿ok¿ on the control box the scan could be finished as planned.Following the scan, the system was shut down, restarted and showed error messages.No patient injury or adverse health consequences were reported as a result of this event, and a rescan was not required.This incident is being reported in an abundance of caution.The incident is currently under comprehensive investigation.A final report will be submitted upon its conclusion, and any new, relevant information will be reported as it becomes available.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The problem was resolved by replacing the defective gantry panel board (gpb).This component has been identified as the root cause and the system has been restored to clinical operation.The replaced hardware was returned for detailed analysis, and no faults were detected under test conditions.A safety assessment has been conducted.No systematic or design-related issues were identified, and further investigation is not required.

• 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: 23049125
• Report Number: 3004977335-2025-00112
• Device Sequence Number: 15888204
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: (01)04056869231044
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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