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

Model Number	10094141
Medical Device Problem Codes	Computer Software Problem (1112); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.During an emergency procedure, the user reported that the c-arm program menu did not appear when the program button on the arm was pressed.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
The investigation of the reported issue was completed by our experts.The investigation of the system logs confirmed that the freeze occurred in the main process of acquisition during system startup and it was caused by a software issue in the ias pc.The system functions were available in the bypass mode.As a result, the c-arm program menu did not appear when the customer pressed the program button on the arm from the pilot module.The ias freezing issue caused the failure of the c-arm menu display.A system restart was initiated by the user via the image visualization system (ivs) which did not resolve the issue as certain low-level processes and hardware components were not re-initialized during the restart sequence.After a complete system shutdown followed by a power-on cycle the system functionality was successfully restored, which reloaded all hardware drivers, clears temporary memory states, and reinitialized critical system components.This comprehensive reset restored normal functionality, which explains why the issue was resolved only after performing a full system shutdown.The root cause of the incident was identified as software hang issue, which was effectively resolved through a full system shutdown and restart as described in the ifu.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 ZEE 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: 22529436
• Report Number: 3004977335-2025-00084
• Device Sequence Number: 8017439
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: (01)04056869010069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 10094141
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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