MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM GO.TOP (CN); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11061648
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause was determined to be customer¿s mis-operation.This is not a product quality related issue, and the system works as specified.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred following use of the somatom go.Top ct scanner.It was reported that the patient's finger was pinched during phs movement.At the time, the caregiver was dragging the patient from the phs to the hospital bed after a scan, however, the phs collided with the hospital bed when accidentally stepping on the foot switch to trigger the phs movement.As a result, the patient¿s finger was pinched.The patient was slightly scratched on the skin of the finger and only disinfection and bandaging was administered.No other medical treatment was needed.

• Brand Name: SOMATOM GO.TOP (CN)
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 25013700
• Report Number: 3003202425-2026-00002
• Device Sequence Number: 21229377
• Product Code: JAK
• UDI-Device Identifier: 04056869151595
• UDI-Public: (01)04056869151595
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173632
• 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): 04/28/2026

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: 11061648
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 04/28/2026
• 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: Unknown