MAUDE Adverse Event Report: Siemens Healthineers AG ARTIS icono biplane; Interventional Fluoroscopic X-Ray System

Model Number	11327600
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers became aware of a malfunction involving an artis icono biplane system operating with software version ve50b.During system use, the messages "limited stand/table movement, sc" and "collision detection disabled, sc - move carefully" were displayed.Subsequently, all system movements became unavailable.The system recovered after a power cycle (system off/on), as described in the user manual for this condition.No patient injury or other health consequences were reported.
Additional Manufacturer Narrative
The log-file investigation revealed that a communication loss caused the mcu board to become unavailable, resulting in the loss of all position information.Consequently, all system movements were blocked.The root cause of the nonconformity was determined to be a software defect.The first issue is a race condition within the "canopenlib" component of the common software function (csf) software, which can result in can communication failures.A second defect in the stand control unit (scu) software prevents the proper detection and recovery of these can communication failures.The described failure affects systems upgraded to software version ve50b.Although the issue may be resolved by system restart, the software upgrade was suspended due to the high frequency of occurrence and because a successful system recovery cannot be assured in all cases.Siemens healthineers has initiated the distribution of a customer safety advisory notice (csan) rough update instruction ax049/26/s to inform affected users of the potential issue and provide appropriate guidance.The update instruction will be reported to the fda as a corrective action.Siemens healthineers continues to investigate the issue and plans to implement a corrective software update for affected systems by the end of the year.

• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; +1(484)323-4197
• MDR Report Key: 50915650
• Report Number: 3004977335-2026-00164
• Device Sequence Number: 17587089
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K254173
• 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
• Report Date (Section B): 09/28/2026

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: 09/22/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown