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

Model Number	08098027
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.A service intervention was performed, during which the broken rear gantry panels and the tube were replaced.The failure of these components was identified as the root cause of the reported problem.After completion of the service measures, the system was successfully restored and handed back to the customer in normal clinical operation.Based on the available information, no general design or manufacturing issue was identified, and no further corrective or preventive actions are deemed necessary.This report is filed with an abundance of caution.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition as ct system.The customer reported a technical malfunction resulting in a gantry down condition and an unsuccessful system checkup.At the time of the event, an acute stroke patient was undergoing a perfusion examination.Due to the technical issue, only a partial perfusion scan and partial contrast media injection were completed.The examination could not be finished on the affected system.The patient was subsequently transferred to another ct system and rescanned after a delay of approximately 20 minutes.According to the information provided, no negative health consequences were caused by the delay in the examination.

• Brand Name: SOMATOM DEFINITION AS
• 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: 25375110
• Report Number: 3004977335-2026-00091
• Device Sequence Number: 9187923
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: (01)04056869003665
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 08098027
• 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: 05/23/2026
• Initial Report FDA Received Date: 06/03/2026
• 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