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

Model Number	11327700
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis icono floor system.During an emergency patient procedure, the unit would not start, which led to a delay.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
Detailed investigation of the reported issue determined that a remote system update (ve40a svp2501) failed.According to the log file analysis, the update was started by the user at 11:41 pm on (b)(6) 2025.While running the software update, the system was in ¿bypass¿ mode and a message was displayed to the user notifying that the unit was offline.The "bypass" mode is an operating mode for various failure scenarios in which basic system functions remain available.This allows the clinical procedure can be completed or stopped in a controlled manner, if necessary.However, the installation was not completed, and since the system was not used or checked as specified in the instruction for use until (b)(6) 2025, the user was not aware of the system issue until the emergency patient arrived.A reboot of the system performed by the user did not solve the problem.However, bypass mode remained available.As part of service activities, the system was restored to its normal state using a backup copy.Parts of the log files were deleted during the restoring attempt, therefore, no conclusive root cause for the issue could be determined.The available information indicates insufficient disk space for the patch installation.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 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: 24022777
• Report Number: 3004977335-2026-00005
• Device Sequence Number: 10719695
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: (01)04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/13/2026

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: 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: 12/29/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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