MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG YSIO X.PREE GEN2; SYSTEM, X-RAY, STATIONARY

Model Number	11574001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: the complaint was made by a siemens employee.A customer contact name and phone number were not provided for reporting purposes.H3, h6: component code g07002 was used for the bracket/stretch grip component.Initial actions (corrective and/or preventive): no general problem has been detected for the installed base which requires immediate action.Manufacturer's preliminary results and conclusion: during the inspection it appeared that the stretch grip may not have been tightened correctly and could therefore move downwards unintentionally.The investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.
Event or Problem Description
Siemens healthiness was notified of an issue with the ysio x.Pree gen2 system during a patient examination.It was communicated that during a lateral chest x-ray procedure, the stretch grip detached and fell.The user had their head below the grip and was struck on the head by the detached grip.The user was diagnosed with a concussion as a result of the impact.No injury of the patient was communicated.

• Brand Name: YSIO X.PREE GEN2
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• 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: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; +1(484)323-4198
• MDR Report Key: 24639286
• Report Number: 3004977335-2026-00039
• Device Sequence Number: 10207664
• Product Code: KPR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250738
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11574001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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 Age: 50 YR
• Patient Sex: Female