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

Model Number	11330002
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of an incident that occurred while operating the somatom x.Ceed unit.The user reported two instances when the system table continued moving without given command and bumped into a staff member.There are no injuries associated with the reported events.
Additional Manufacturer Narrative
Siemens local service engineer was dispatched to the customer site.The engineer exchanged hardware components, and the issue has not re-occurred since the repairs.This adverse event report is submitted with an abundance of caution.A supplement report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.The returned gpb was subjected to a detailed analysis.The investigation identified a mechanical failure of the internal mechanism of the 'move' button, which resulted in a "sticking" condition.The reported issue was resolved by replacing the defective front left control panel (gpb) and the central unit of the control system located in the stationary part of the gantry (imas).The system has since been returned to clinical operation.The consumption rate of these spare parts is monitored through our corrective and preventive action (capa) process and remains within acceptable thresholds relative to the installed base.This data confirms that the identified issue is not indicative of a product or design flaw.A safety assessment has been performed, and no general product or design issue was identified.

• Brand Name: SOMATOM X.CEED
• 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: 22382374
• Report Number: 3004977335-2025-00079
• Device Sequence Number: 9417944
• Product Code: JAK
• UDI-Device Identifier: 04056869231051
• UDI-Public: (01)04056869231051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 11330002
• 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: 06/08/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/12/2025
• 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