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

Model Number	AZURION 3 M15
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system software was unable to boot up.The device was outside 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 additional information collected, the system was not in clinical use when the issue was identified.The philips field service engineer (fse) inspected the system on-site and confirmed that the system software was unable to boot up.Upon troubleshooting, the philips field service engineer (fse) checked the system on-site and found that the system software had crashed and logging was not possible.The fse attempted a system software reinstall, which failed because of x-ray pc errors.Initially the suite pc hdd was suspected, and a replacement was ordered, but further inspection showed the x-ray pc hdd was at fault.To resolve the issue, the fse returned the suite pc hdd as good and sealed, replaced the x-ray pc hdd and reinstalled the complete software.After replacement, the system returned to use in good working order.The codes were updated based on the investigation outcome.

• 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: 23679844
• Report Number: 3003768277-2025-015435
• Device Sequence Number: 9984246
• Product Code: OWB
• UDI-Device Identifier: 00884838085282
• UDI-Public: (01)00884838085282
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 03/13/2026

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 3 M15
• Device Catalogue Number: 722064
• 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: 11/23/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• 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