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

Model Number	11330001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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 as soon as the investigation is completed, or new information has become available.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom x.Cite ct scanner.The customer reported that during the perfusion scan of a 60-year-old, female patient, he had issues processing the data.The patient underwent a three-part examination consisting of a non-contrast head ct, perfusion imaging, and cervical artery imaging.While perfusion maps were being processed, the necessary diagnoses were already made from the cervical artery images.Therefore, repeating the perfusion scan was unnecessary.The customer reported a delay in diagnosis of approximately 15 minutes which did not cause any negative health consequences to the patient.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined as a software error.Siemens thoroughly analyzed the logfiles of this incident and found a software error which led to a data processing issue.The logic for creating the volumes did not work properly with this specific dataset.When calculating the gradient for the 19th slice, the condition was satisfied for affinity towards the next timepoint at the peak / valley.Therefore, the next volume was created with the last slice of the previous dataset.This is the first time this software issue has occurred.A safety assessment has been performed.The issue is understood, and a solution is considered for upcoming sw-versions or service packs.

• 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: 21908197
• Report Number: 3004977335-2025-00056
• Device Sequence Number: 8712864
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: (01)04056869231044
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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