MAUDE Adverse Event Report: Siemens Healthineers AG Luminos Agile Max; Interventional Fluoroscopic X-Ray System

Model Number	10762472
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of a malfunction involving a luminos agile max system.According to the siemens service engineer, the system's emergency stop button was found to be broken and nonfunctional.No patient injury, user injury, or adverse event was reported in connection with this malfunction.Although no injury occurred in this event, the inability to actuate the emergency stop button could, in a worst-case scenario, delay or prevent the interruption of system motion during an emergency.If no alternative emergency stop buttons were activated, a serious injury to a patient or operator could potentially occur.
Additional Manufacturer Narrative
H3, h6: initial actions (corrective and/or preventive): no immediate action is necessary for the affected site.The emergency stop button was replaced and tested for functionality.Based on the information available, no general issue affecting the installed base has been identified that would require immediate corrective or preventive action.Manufacturer's preliminary results and conclusion: siemens healthineers initiated an investigation into the reported malfunction.At the time of this report, the root cause of the defective emergency stop button has not been determined.The investigation remains ongoing.A supplemental report will be submitted to the fda upon completion of the investigation and when additional information becomes available.

• Brand Name: Luminos Agile Max
• 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: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; +1(484)323-4198
• MDR Report Key: 50916381
• Report Number: 3004977335-2026-00166
• Device Sequence Number: 5778099
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: (01)04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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: 10762472
• 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: 09/11/2026
• 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