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

Model Number	11605361
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction.The investigation determined that a foreign object was present within the scan field of view during the air calibration.The calibration table data showed a moving inhomogeneity across the ten air calibration segments, clearly confirming the presence of an external object.The observed image artifact resulted from a user operating error during air calibration.Users are required to verify prior to each air calibration that the gantry contains no objects.This requirement is explicitly stated in the instructions for use (print no.C2 070a.621.01.03.02), chapter 15.2.2 ¿system calibration,¿ page 264: ¿to start the calibration procedure, make sure all objects are removed from the scan field and no patient is loaded.¿.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom on.Site ct system.Based on the information available, artifacts were present in the scan of a 2-year-old emergency patient.As a result, the scan was repeated, but the image artifacts persisted.The procedure was continued and completed on an alternate system.It was reported that the patient passed away in the days following the examination; however, the child's death was not related to the reported issue regarding the medical device.Additional information on the circumstances of the patient¿s death was requested from the user facility, but no further details were provided.

• Brand Name: SOMATOM ON.SITE
• 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: 24330922
• Report Number: 3004977335-2026-00023
• Device Sequence Number: 20062239
• Product Code: JAK
• UDI-Device Identifier: 04056869973180
• UDI-Public: (01)04056869973180
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K241295
• 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): 02/13/2026

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: 11605361
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/13/2026
• 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: 24 MO
• Patient Sex: Unknown