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	08/08/2026
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).No patient injury or other health consequences were reported.
Additional Manufacturer Narrative
Siemens is conducting an investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.

• 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: 50916064
• Report Number: 3004977335-2026-00165
• Device Sequence Number: 14952137
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown