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

Model Number	08098027
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The investigation determined that the collision was caused by a metal handle on the table manufactured by maquet gmbh that was not in its intended closed position.The reason why the handle was not in the intended position at the time of the scan could not be determined.The table is validated for use in combination with the sliding gantry system; however, no communication interface exists between the table and the ct system (¿the [maquet] operating table system is not connected to the sliding gantry ct.¿ ¿ ifu sliding gantry, print no.Hc-c2-x05.610.32.08.02, p.62).The instructions for use include a warning that injuries or damage may occur if the table is not positioned in the ct position (¿table not in ct position! - injury to the patient or personnel.- avoid collision of the gantry and the patient, or collision of other objects in the examination room with the gantry.¿ - ifu sliding gantry, print no.Hc-c2-x05.610.32.08.02, p.13).Based on the investigation results, the ct system operated in accordance with its specifications.No device malfunction was identified.A safety assessment was performed, and no additional risks to patients or users were identified.No further actions, including corrective or preventive measures, are deemed necessary.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the somatom definition as ct system.The customer reported that, during a patient scan, the sliding gantry of the ct system collided with a table from the manufacturer maquet gmbh.No adverse health effects for the patient were reported, and no rescan was necessary.Material damage to the ct system covers and internal components was reported.

• 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: 24909461
• Report Number: 3004977335-2026-00064
• Device Sequence Number: 21314333
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: (01)04056869003665
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• 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): 04/17/2026

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: 04/09/2026
• Initial Report FDA Received Date: 04/17/2026
• 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: 54 YR
• Patient Sex: Female