MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	AZURION 7 M12
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's footswitch charger was not working, which can impact imaging.The device was in clinical use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the procedure was completed as planned using a wired footswitch.The field service engineer (fse) inspected the system onsite and confirmed that the pedal charger was not working.The fse replaced the wireless footswitch charger (wfsc), restoring normal system functionality.After replacement, the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude a potential for serious injury; and as such, the complaint was reported.Since that time, new information has been received which has confirmed that the issue is related to the inability to charge the wireless footswitch with the charger.As per the instructions for use, when using the wireless footswitch, it is required to ensure that the wired footswitch is connected and available for use.Through the use of an alternate footswitch, in the event of a wireless footswitch failure, any procedure would be able to be completed with minimal or no delay; the malfunction would not likely lead to a death or serious injury.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.The fda establishment registration number [fei] has been updated and reported to the fda, changing from 3003768277 to 3042175844, effective december 21, 2025.This change reflects as administrative registration update only.There have been no changes to the registered owner/operator, official correspondent, legal entity name, physical establishment address, manufacturing processes, or to the design, specifications, intended use, or manufacturing processes of any listed devices.

• Brand Name: AZURION
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: marjan vos ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 24232138
• Report Number: 3003768277-2026-100491
• Device Sequence Number: 8981145
• Product Code: OWB
• UDI-Device Identifier: 00884838085251
• UDI-Public: (01)00884838085251
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K172822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: AZURION 7 M12
• Device Catalogue Number: 722078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown