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

Model Number	11107464
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: manufacturer's preliminary results and conclusion: the user must ensure that the patient's fingers are not endangered when moving the table.No general issue was identified in the field.The investigation is ongoing.A supplemental report will be submitted if additional reportable information is received from the customer or upon investigation completion.
Event or Problem Description
Siemens healthineers was notified on march 6, 2026, via medwatch report # (b)(4), of a patient event involving the ysio x.Pree system.It was stated, while moving the patient table, the patient¿s fingers were pinched.Additional follow-up by siemens healthineers revealed that the patient did not sustain any injury from the event.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.The investigation showed that the patient¿s hand was positioned outside of the safe area during table movement.In general, it is the responsibility of the operator to ensure that no part of the patient's body lies within hazardous areas before activating any mechanical movement.Furthermore, the operator must ensure that the patient uses the handles and thus does not grasp the ends or sides of the tabletop.This is also described within the operator manual xpb7-040g.620.01.03.02 in chapter ¿accessories and auxiliary devices¿.According to the information received no handgrips were used in this case.If an obstacle, such as a patient's finger, is present during table movement, this can be noticed by the operator immediately when the table is moved manually since the movement becomes less smooth.The ysio table was designed to comply with iec 60601-1:2005 table 20 ¿acceptable gaps¿.This ensures that every table is in alignment with the acceptable gap tolerances of smaller than 8mm.Each manufactured ysio table complies with this and no tolerances are exceeded.This is valid for all ysio tables (classic/ max/ x.Pree).No system malfunction could be identified.The system works as specified.The complaint is closed.No further action is needed.

• Brand Name: YSIO X.PREE
• 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 ; 4843234198
• MDR Report Key: 24629194
• Report Number: 3004977335-2026-00037
• Device Sequence Number: 8698538
• Product Code: KPR
• UDI-Device Identifier: 04056869232904
• UDI-Public: (01)04056869232904
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 11107464
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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 Sex: Unknown