MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO X.PREE; SYSTEM, X-RAY, STATIONARY

Model Number	11107464
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient laying supine in an oblique position, left side being away from the table.Tech was standing on the pt's right side.Tech floated table and patient responded that fingers were pinched.Pt's left hand had been grasping around tables edge.The table did not give warning.Upon investigation, table was working as intended.Company confirmed there are no safety mechanism when utilizing floating movements.

• Brand Name: YSIO X.PREE
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 333 coney street; east walpole MA 02032
• MDR Report Key: 24531269
• Report Number: 24531269
• Device Sequence Number: 15720963
• Product Code: KPR
• UDI-Device Identifier: 04056869232904
• UDI-Public: 04056869232904
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026
• Report Date (Section F): 02/19/2026

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: Other
• Device Model Number: 11107464
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/19/2026