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

Model Number	11327700
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 floor system.During an emergency patient procedure, no x-ray release was possible.The patient was moved, and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the patient involved.
Additional Manufacturer Narrative
The investigation of the reported event was completed by siemens experts.Log file analysis confirmed that the system was unable to perform x-ray release.The error message: ¿no xray ¿ all focuses defect.Call service¿ was displayed to the user.The on-site service intervention determined that all three foci were malfunctioning.As part of trouble shooting, the high-voltage (hv) cable pins were replaced, and the system was brought back to specifications.No residues or burn marks were observed on the replaced pins.Therefore, the exact root cause could not be determined.It is assumed that poor electrical contact at the high-voltage (hv) cable plug was the cause of the issue, potentially due to improper seating of the connector or incorrect application of silicone oil.The occurrence rate of the identified cause has been checked, and no error accumulation has been identified.The occurrence rate is below the defined threshold.

• Brand Name: ARTIS ICONO FLOOR
• 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: 22849454
• Report Number: 3004977335-2025-00101
• Device Sequence Number: 8458107
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: (01)04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 11327700
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown