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

Model Number	ALLURA XPER FD20/10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips investigated the complaint and dispatched a field service engineer (fse) to inspect the system onsite.The fse confirmed that the system was unable to boot.During troubleshooting, the issue was traced to the flex vision pc, which was stuck at 0.To resolve the issue, the customer replaced the flex vision pc but was unable to complete the repair.The fse then reloaded the board software onto the new unit to finalize the process.Following the replacement and software reload, the system was restored to normal operation and returned to use in good working condition.The codes were updated based on the investigation outcome.
Event or Problem Description
It was reported to philips that the system was unable to boot, stalling at 00:00.The device was outside of clinical use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.

• Brand Name: ALLURA XPER FD
• 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: 23386273
• Report Number: 3003768277-2025-013100
• Device Sequence Number: 13023234
• Product Code: OWB
• UDI-Device Identifier: 00884838054219
• UDI-Public: (01)00884838054219
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162859
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 FD20/10
• Device Catalogue Number: 722029
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2014
• 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