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

Model Number	10742326
Medical Device Problem Codes	Failure to Sense (1559); Radiation Overexposure (3017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be hardware error.The reported issue was addressed by replacing a position sensor (sp wire sensor) in the patient handling system (phs).Following the replacement, the system was verified to be fully functional.An evaluation of material consumption relative to the installed base, as monitored through the capa process, demonstrated that usage levels remain within established specifications.No systemic product issue or design related deficiency could be identified.Therefore, no additional investigation is considered necessary.A safety assessment was performed, and no increased risk to patients or users was identified.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom force ct system.Based on the information available, a perfusion scan was aborted and subsequently had to be repeated.As a result, the acute stroke patient required a second scan and a second administration of contrast medium.The scan abort caused a delay of approximately 15 minutes in establishing the diagnosis.No injuries or adverse health effects have been reported in connection with this event.

• Brand Name: SOMATOM FORCE
• 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: 24276585
• Report Number: 3004977335-2026-00018
• Device Sequence Number: 8253798
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: (01)04056869006956
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 10742326
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/06/2026
• 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: 75 YR
• Patient Sex: Male