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	Needle Stick/Puncture (2462)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the fluoroscopy foot pedal was not functioning.The device was in clinical use at the time of the event.The patient¿s procedure was cancelled and rescheduled due to the loss of fluoroscopy functionality.Philips has started an investigation of this complaint.

• 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: 50943850
• Report Number: 3042175844-2026-002668
• Device Sequence Number: 10451919
• Product Code: IZI
• UDI-Device Identifier: 00884838059054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Allura Xper FD20
• Device Catalogue Number: 722012
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 11/05/2020
• 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