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

Model Number	11061630
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The investigation did not identify an underlying failure mechanism, and no definitive root cause could be established.A comprehensive technical investigation was performed based on the data provided.The available system logs were reviewed; however, they were not sufficient to determine the root cause of the issue.Specifically, no extended save log or system dump files were available for analysis, and the reported behavior could not be reproduced.The investigation did not identify an underlying failure mechanism, and no definitive root cause could be established with the information provided.As a temporary mitigation, restarting the system restored normal functionality of the reconstruction process.No further technical investigation was possible due to the lack of additional diagnostic data.A safety assessment was conducted and no corrective or preventive actions were implemented.
Additional Manufacturer Narrative
Siemens is currently conducting a comprehensive investigation of the reported issue.As the investigation is ongoing, the root cause has not yet been established.A supplemental report will be submitted as soon as additional relevant information becomes available, and a final report will be provided upon completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of an incident that occurred while operating the somatom go.All ct system.Based on currently available information, the reconstruction of an examination performed on an acute stroke patient failed to execute.Following the incident, the user restarted the system, after which the reconstruction functioned normally.This resulted in a reported diagnostic delay of approximately 10¿15 minutes.No injuries or adverse health effects have been reported in connection with this event.

• Brand Name: SOMATOM GO.ALL
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: 24589363
• Report Number: 3004977335-2026-00034
• Device Sequence Number: 9386000
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: (01)04056869151564
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K250822
• 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): 04/24/2026

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: 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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 Age: 37 YR
• Patient Sex: Male