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

Model Number	AZURION 5M20
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system gave an alert indicating x-ray tube problem, only low-load fluoroscopy possible, impacting imaging.No harm was reported to philips.The device was in clinical use at the time of reported event.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigated the complaint.Additional information collected confirmed that the system was not in clinical use at the time the event occurred.An error image was sent to the philips remote service engineer (rse) indicating: "x-ray tube problem, only low-load fluoroscopy possible." the rse inspected the hospital power panel and found that the cooling unit (clu) was not turning on, the pressure valve was not set to high, and the adu rotation state led was off.The rse instructed the user to set the valve to high, check the clu oil level, and disconnect and reconnect the adu and xsc cables.After these actions, the equipment was powered on again.The clu activated, and the adu rotation state led illuminated green.Additionally, review of the system log file indicated issues related to the clm flow switch, which resulted in no exposure and allowed only low-load fluoroscopy.After following the instructions provided by the rse, the device passed the image acquisition test and the system was restored to normal operation.The system was returned to clinical use in good working condition.At the time the complaint was received, philips did not have sufficient information to exclude the potential for death or serious injury upon recurrence; therefore, the complaint was reported.Subsequent review identified that the issue occurred without patient involvement and was identifiable prior to procedure commencement.It was determined that recurrence of this issue is not likely to cause or contribute to death or serious injury.Per the instructions for use, the user must institute a user routine checks program and ensure that all checks and actions are satisfactorily completed before using the product for its intended purpose.The product should not be used until these checks have been completed.As the device was not in clinical use when the issue was identified, the user would have identified the issue prior to use.Based on re-evaluation, this case is not reportable.The codes have been 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: 23830571
• Report Number: 3003768277-2025-015781
• Device Sequence Number: 9288209
• Product Code: OWB
• UDI-Device Identifier: 00884838099234
• UDI-Public: (01)00884838099234
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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 5M20
• Device Catalogue Number: 722228
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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