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

Model Number	AZURION 5 M12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to boot.The device was outside of 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.The philips field service engineer (fse) inspected the system onsite and confirmed that the acquisition software was not completing the boot process.A review of system log files confirmed that the system failed to boot.Further investigation identified the pdu firmware status as red, indicating a firmware related issue.The fse reinstalled the latest available version of the pdu firmware, after which the system powered on normally.Multiple restart tests were performed, and the system consistently booted successfully.After reinstalling the firmware, the system was 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: 24630056
• Report Number: 3042175844-2026-000226
• Device Sequence Number: 9015316
• Product Code: OWB
• UDI-Device Identifier: 00884838099227
• UDI-Public: (01)00884838099227
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200917
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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 5 M12
• Device Catalogue Number: 722227
• 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: 03/07/2026
• Initial Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 04/08/2022
• 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