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

Model Number	11327600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred on the artis icono biplane unit.The arm of radiation protection shield was reported to be damaged.Detailed clarifications of this event are currently ongoing; therefore the event is reported in doubt.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
Section h6 g07002 - support arm.The investigation of the reported issue showed that the swivel joint of the extension arm of the upper radiation protection shield was damaged, causing the support arm to bend toward the floor.According to the system expert, the reported collision between the c-arm and the support arm likely occurred during a user-controlled system movement.Such collision can occur if the user does not check for possible obstacles before releasing system movements.The operator manual provides adequate instructions regarding system movement and how operators can avoid collisions, see chapter 7.1 ¿safety instructions ¿ system movements.Risk of collision, risk of injury to patient or operator, risk of damage to unit parts.¿ it is the responsibility of the operator to ensure that unit movements are released only if it is certain that neither the operator, the patient, third parties nor other pieces of equipment can be endangered by these movements.Always pay attention to possible collisions during unit movements.Make sure that nobody is standing inside the danger area.Remove any objects or accessories from collision area, e.G.Injector or infusion stand.The damaged support arm was replaced by siemens local service.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 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 ; 4843234197
• MDR Report Key: 23728116
• Report Number: 3004977335-2025-00140
• Device Sequence Number: 10258791
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/17/2026
• 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