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

Model Number	11061640
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be improper handling.The reported issue was resolved by replacement of the damaged plexiglass ring.The system was inspected for any additional damage, and no further abnormalities were identified.The system was returned to clinical operation and is functioning as specified.The root cause of the incident was determined to be improper handling, as the patient unintentionally collided with the plexiglass ring.Information regarding patient handling is clearly outlined in the instructions for use (print no.C2-082b-g.621.05.03.02, chapter 2.4.4, p.28): ¿observe the following safety information when securing the patient on the table.Unintentional patient movement! injury to the patient.Always fix and observe the patient during the measurement.¿ no further technical investigation is deemed necessary, and a safety assessment has been performed.Assessment does not indicate a system failure or malfunction, and no non-conformity was identified.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom go.Top ct scanner.According to the information provided, the patient hit the plexiglass ring located in the center of the gantry with his knee, resulting in damage to the component.The patient sustained minor abrasions to the knee, which were treated with minor first aid.No serious or long-term health consequences have been reported.

• Brand Name: SOMATOM GO.TOP
• 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: 25373359
• Report Number: 3004977335-2026-00090
• Device Sequence Number: 16104428
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: (01)04056869151571
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11061640
• 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: 05/22/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male