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

Model Number	11327600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
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
Siemens became aware of a malfunction that occurred while operating the artis icono biplane system.During a patient procedure, the side controls were flashing.On november 17th, 2025, additional information was received that the emergency stop button was permanently activated during the procedure.This resulted in patient being moved to proceed with the procedure on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Section h6 code g07002 - pilot module.The investigation of the reported event was completed by our experts.The log file analysis revealed that several modules were inactive from the pilot module, and the operating module could not be reached.Consequently, system operation via the pilot module (operator room) was no longer possible.Siemens local service engineer visited the site to assess the issue.Upon inspection, it was identified that the cable connected to the pilot module had become loose at the entry point.Twisting and/or pulling of the cable resulted in the breakage of three internal wires.The service engineer replaced the affected pilot module cable during the service intervention, after which the system functionality was successfully restored.The returned part was inspected; and broken internal wires as well as lack of electrical continuity were confirmed.These findings were consistent with the engineer¿s on-site assessment.The exact cause of the loose cable and subsequent breakage could not be conclusively determined.However, a possible explanation is that the strain relief may have not been properly secured, or it may have loosened over time due to external mechanical forces.The pilot module is a main component for system control.In the event of pilot module failure, the following operational restrictions can be expected: - restricted stand movements.- operation limited to slow speed.- no automatic runs available.- if the system is in park position, no basic system functions are available (no x-ray generation and no system movement).The root cause of the non-conformity was determined to be an issue in the pilot module cable, specifically broken internal wires leading to loss of functionality.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 ICONO 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 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 23618868
• Report Number: 3004977335-2025-00135
• Device Sequence Number: 15943169
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K241572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 11327600
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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