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	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system gave an alert indicating x-rays were not possible, 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 planned treatment was being performed when the issue occurred and was completed after performing the system calibration with a delay of less than 20 minutes.Customer reported to philips that the system gave an alert indicating x-rays were not possible.The philips remote service engineer (rse) inspected system remotely and attempted to calibrate the small focus, but it was unsuccessful because the customer was facing power input problems.Customer resolved the power issue then both the filaments were working fine, after which the rse performed tube calibration, entrance dose limit calibration (edl).The x-ray emission tests were verified, and the system was returned to use in good working condition.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 led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.According to the information obtained, the procedure was not impacted, and it was completed after performing the system calibrations with a delay of less than 20 minutes.The procedure was successfully completed with a minimum delay on the same system and is unlikely to result in or contribute to death or serious injury if it were to happen again.Therefore, based on this investigation results, philips concludes that this complaint is not reportable.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: 23898012
• Report Number: 3003768277-2025-015941
• Device Sequence Number: 5129064
• Product Code: OWB
• UDI-Device Identifier: 00884838085282
• UDI-Public: (01)00884838085282
• 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): 01/29/2026

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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2019
• 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