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

Model Number	11327600
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens healthineers that a malfunction occurred while operating the artis icono biplane.After system started up, stand movements were not possible and a stand/table error was displayed.
Additional Manufacturer Narrative
The investigation was performed on expert discussions (considering complaint description, customer service reports, system history, log file analysis).After system started up, stand movements were not possible and a stand/table error was displayed.The investigation showed that a software issue in the stand and table control unit (scu) caused the system to block all movements.The software allowed the sid to move beyond its defined limit, which triggered a safety error and stopped stand, table, and fd lift movements.This issue has been identified as a systematic issue which may occur repeatedly and lead to a serious injury, and can only be resolved by service intervention.The issue was resolved by resetting the system position and running the reference procedure for the fd lift.Following this service action, normal movement functionality was restored.A software update (ve40b patch 5 for icono with sinumerik one) was defined as a field safety corrective action to address the identified scu software issue.

• 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: marion mints ; 40 liberty blvd.; malvern, PA 19355 ; 4843231632
• MDR Report Key: 24830224
• Report Number: 3004977335-2026-00048
• Device Sequence Number: 21387418
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection,Recall
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 04/01/2026
• Initial Report FDA Received Date: 04/09/2026
• 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