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

Model Number	11330001
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom x.Cite ct scanner.The customer reported difficulties initializing a pre-monitoring scan for a stroke protocol.The patient was safely removed from the system and transferred to an alternate system where the scan was completed.A delay of approximately 20 minutes occurred, and the topogram had to be repeated.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.
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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause could not be determined due to insufficient information.Siemens attempted to contact the customer to arrange an on-site visit for the collection of the log files required for the investigation.The customer did not grant system access until (b)(6) 2026, at which time the relevant data had already been overwritten.As the system is not connected to our server infrastructure, no retrievable data was available for analysis.Based on the limited information provided, no further investigation could be conducted.The investigation is therefore closed due to insufficient information.No additional complaints have been received from this customer since the event, suggesting that the issue has not recurred.A safety assessment was conducted, and no general product or design issue could be identified.

• 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: 23778438
• Report Number: 3004977335-2025-00142
• Device Sequence Number: 13280849
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: (01)04056869231044
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/09/2026
• 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