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

Model Number	10590100
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, the root cause has not yet been determined.A supplement report will be filed once new findings are available or the case has been fully analyzed.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom confidence ct scanner located in germany.The customer reported the following system behavior: when using the rt_resp scan protocol in combination with the open interface, the respiratory curve is imported into the system after the scan.Subsequently, image reconstruction is performed in ¿average¿ mode as well as in multiphase series with phases ranging from 0% to 100% in 10% increments.It was observed that, sporadically, the series descriptions and the image contents do not match.Although the series are labeled with different phase identifiers (e.G., 0%, 10%, 20%, etc.), the images show identical content, and the patient¿s respiratory motion is not visible.When the reconstruction is repeated, the resulting images are correct and display the expected differences in respiratory phases.These ct images are used for radiotherapy planning.It can be ruled out that the images are used directly for treatment delivery, as they are first imported into an external planning system.The actual treatment planning is then performed by medical physicists and physicians.During this step, the described issue (unchanged images across different respiratory phases) is clearly detectable.Therefore, it can be excluded that the faulty image dataset would lead to incorrect radiation delivery.Nevertheless, the error occurs within the radiotherapy planning workflow and thus represents a potential patient risk, even if only theoretically in this case.This event is being reported in the abundance of caution.
Additional Manufacturer Narrative
H3, h6: siemens healthineers has completed a thorough investigation of the reported incident.No technical malfunction was identified in the ct system, and the system operates in full accordance with its specifications.Nevertheless, a workaround was provided to the customer to prevent recurrence of the reported behavior.The assessment indicates that the issue originates from the customer¿s respiratory gating system (third party device).The reconstructed images on the ct side were correct, and no anomalies were detected in the event logs or savelogs of the ct system.The customer was informed that the behavior appears to occur when the reconstruction results are accessed before the reconstruction process has fully completed.They were therefore advised to wait briefly after the reconstruction is finished before attempting to load the results.In discussions with the customer, it was reported that the problem no longer occurs when they wait after importing the breathing curve and refrain from using the auto-reconstruction function.The customer prefers not to modify the established reconstruction sequence, in which axial reconstruction precedes multiphase reconstruction.As a result, they will discontinue the use of auto-reconstruction and initiate reconstructions manually going forward.The investigation results were understood and accepted by the customer.The case was closed in mutual agreement with the customer; no further investigations are required.A risk assessment has been conducted.

• Brand Name: SOMATOM CONFIDENCE
• 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: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 23377456
• Report Number: 3004977335-2025-00122
• Device Sequence Number: 18358660
• Product Code: JAK
• UDI-Device Identifier: 04056869011011
• UDI-Public: (01)04056869011011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230421
• 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
• Report Date (Section B): 03/11/2026

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: 10590100
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/11/2026
• 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