MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number	ALLURA XPER FD20
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to perform exposure.The user performed a restart, but the issue persisted.The device was in clinical use at the time of the 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 patient was transferred to another device to continue the procedure.The philips field service engineer (fse) inspected the system onsite and confirmed that the system was unable to make exposure and the system reported "tube defect".The fse measured the small and large focus filament inductance and found that the cause is related to filament open circuit.To resolve the issue x-ray tube was replaced.The x-ray tube was returned for further analysis.Functional testing was performed the tube failed with both filaments blown after intensive usage.After replacement of the x-ray tube, the system was returned to good working condition.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to additional information collected, the patient was transferred to another device to continue the procedure.The philips field service engineer (fse) inspected the system onsite and confirmed that the system was unable to make exposure and the system reported "tube defect".The fse measured the small and large focus filament inductance and found that the cause is related to filament open circuit.To resolve the issue x-ray tube was replaced.The x-ray tube was returned for further analysis.Functional testing was performed the tube failed with both filaments blown after intensive usage.After replacement of the x-ray tube, the system was returned to good working condition.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: ALLURA XPER FD
• Common Device Name: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 23931845
• Report Number: 3003768277-2025-015990
• Device Sequence Number: 5625956
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• UDI-Public: (01)00884838059054
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130842
• 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,Followup
• Report Date (Section B): 04/03/2026

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: ALLURA XPER FD20
• Device Catalogue Number: 722012
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 04/01/2026; 04/01/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/02/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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