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

Model Number	11061630
Medical Device Problem Codes	Computer Software Problem (1112); Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a technical issue occurred while operating the somatom go.All ct system.The customer reported that the perfusion evaluation of a 66-year-old male stroke patient was not possible.The customer tried to open the patient in ct perfusion and received an error message that the patient is already opened.The customer was able to reconstruct the images after a delay of approximately 15 minutes.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order 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 healthineers conducted a thorough investigation of the logfiles of the reported event.The following root cause was identified for the reported issue.The previous workflow performed by the user couldn't be completed due to an unhandled exception.The customer was not able to re-start the current workflow until the previous was closed.This is a known software error that was reported to siemens for the first time for this particular software version.A solution is considered for future software versions/service packs.Siemens is unaware of the reported error reoccurrence, and the customer has not been able to reproduce it.

• Brand Name: SOMATOM GO.ALL
• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 22182855
• Report Number: 3004977335-2025-00073
• Device Sequence Number: 15625980
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: (01)04056869151564
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 11061630
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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 Age: 66 YR
• Patient Sex: Male