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

Model Number	11574001
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens healthineers was notified of a patient injury involving the ysio x.Pree gen2 system.It was stated that a flipped image was used for surgical planning resulting in the surgery being performed on the wrong hip.
Additional Manufacturer Narrative
E1: a facility contact name and phone number were not provided for reporting.H3, h6: initial actions (corrective and/or preventive): currently no general problem has been detected for the installed base which requires immediate action.Manufacturer's preliminary results and conclusion: the investigation is ongoing.A supplemental report will be submitted upon receipt of additional reportable information and/or investigation completion.
Event or Problem Description
Additional information.Siemens healthineers received additional information on march 18, 2026, stating that there was no actual incorrect hip surgery nor was there any surgery was planned based on the images taken on the reported ysio x.Pree system.Therefore, the reported issue is no longer classified as reportable.
Additional Manufacturer Narrative
H11 corrected data: h3, h6: based on additional information received by siemens healthineers on march 18, 2026, there was no patient harm since a hip surgery was not performed or planned on the incorrect hip based on the images taken.Based on this information, the issue is no longer reportable.

• 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 ; 4843234198
• MDR Report Key: 24589012
• Report Number: 3004977335-2026-00033
• Device Sequence Number: 5724691
• Product Code: KPR
• UDI-Device Identifier: 04056869962214
• UDI-Public: (01)04056869962214
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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