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

Model Number	10094141
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Siemens became of a malfunction that occurred while operating the artis zee biplane unit.During an emergency catheterization procedure, fluoroscopy imaging became unavailable.The patient had to be moved to complete the procedure on an alternate system.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.The investigation was performed based on complaint description, customer service reports, system history, system log files, and expert review.According to the log file analysis, as soon as the operator released x-ray on plane a, the digital image pre-processing (dipp) detected a failure which initiated an automatic reset lasting about one minute, and blocked x-ray during this period.Once the system restarted, x-ray on plane b was available; however, the customer did not attempt to use plane b.During onsite troubleshooting, customer service engineer (cse) found problem with copra board in the front control unit on plane a.Cse performed the replacement of copra board and tested functionality, the issue was resolved.An extensive investigation could not be performed because the affected part (copra board) was not returned.Therefore, the exact cause of the complaint could not be determined retrospectively.The relevant root cause for the non-conformity was issue with the copra board.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: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 23348063
• Report Number: 3004977335-2025-00121
• Device Sequence Number: 7807198
• 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): 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): 12/04/2025

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: 10/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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