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

Model Number	ALLURA XPER FD20 OR TABLE
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to boot up.The device was not 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.The philips remote service engineer (rse) examined the system remotely and confirmed that the system was unable to boot, stalling at 00:00.Review of the logfile shows malfunctioning flex vision pc.Upon troubleshooting, the philips remote service engineer (rse) checked the system remotely and the customer stated that the issue was temporarily resolved by powering the large screen control pc off and on via cabinet b.The rse checked the system logfile and found a failure in the flex vision monitoring and recommended an onsite visit.The philips field service engineer (fse) checked the system onsite and found that the control pc for the large screen monitor in the examination room was not starting correctly, which caused the malfunction.The fse found an error message indicated a faulty frame grabber card in the control pc.To resolve the issue, the fse replaced the flex vision pc, installed the required software, and performed multiple checks.The defective part was sent for analysis, for flexvision pc no failure was observed.Due to manufacturing issues, the frame grabber card may not function as intended, leading to issues with the system's flexvision pc.Philips has initiated a medical device correction (z-1144-2024).After replacement, the system returned to use in good working order.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 (b)(6) 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: 23744407
• Report Number: 3003768277-2025-015594
• Device Sequence Number: 21419946
• Product Code: IZI
• UDI-Device Identifier: 00884838059085
• UDI-Public: (01)00884838059085
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/21/2026

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 OR TABLE
• Device Catalogue Number: 722023
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1144-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown