MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848282
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Image process problem during operation.Hospital¿s ae report described incident as ¿on (b)(6) 2025, a patient underwent semi-permanent venous catheter placement and removal surgery using a siemens artis biplane x-ray angiography system in the interventional operating room of (b)(6).During the procedure, the image processing system went black, but recovered after multiple restarts.Further examination determined a faulty image processing board, and the manufacturer was contacted for immediate replacement." notification no.Is (b)(6).
Additional Manufacturer Narrative
The investigation was conducted by our experts.Log file analysis identified an issue during the initialization of the copra (common processing architecture) board.The system message ¿no x-ray, fd problem, sc¿ was displayed to the user.During an onsite troubleshooting, siemens local service engineer identified a malfunction in the copra board, which is a sub-component in real-time controller (rtc) in plane a.The engineer replaced the rtc in plane a, rebooted the system, and verified system functionality.Following these actions, the issue was resolved.An extensive investigation could not be performed due to the affected component (rtc) not being returned.Therefore, the exact cause of the complaint could not be determined.It is assumed that the root cause for the non-conformity is a malfunction of copra board in rtc.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: anastasia sokolova ; 40 libety blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 23568962
• Report Number: 3004977335-2025-00132
• Device Sequence Number: 10155653
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: (01)04056869009995
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181407
• 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,Followup
• Report Date (Section B): 02/11/2026

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: 10848282
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• 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