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

Model Number	ALLURA XPER FD20/15
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's geometry module button was damaged.Upon rebooting, the system was unable to boot, stalling at 00:00.The device was in clinical use at the time of the event.No harm to the patient or user was reported.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigated this complaint.According to the additional information collected, the neurovascular procedure had been performed, and the procedure was completed with the same geometry module because the button had only cosmetic damage.The philips field service engineer (fse) inspected the system onsite and confirmed that the system failed to complete the boot process.The original geometry module was reinstalled, but the system continued to fail to boot.Review of the system log files determined that the flex vision pc was not communicating with the host pc.During boot-up, power was present at the flex vision pc, but the pc itself remained powered off.Further troubleshooting determined that the ttcf board was defective.To resolve the issue, the fse replaced the board.The system was returned to service in good working order.The codes were updated based on investigation outcome.
Additional Manufacturer Narrative
Philips investigated this complaint.According to the additional information collected, the neurovascular procedure had been performed, and the procedure was completed with the same geometry module because the button had only cosmetic damage.The philips field service engineer (fse) inspected the system onsite and confirmed that the system failed to complete the boot process.The original geometry module was reinstalled, but the system continued to fail to boot.Review of the system log files determined that the flex vision pc was not communicating with the host pc.During boot-up, power was present at the flex vision pc, but the pc itself remained powered off.Further troubleshooting determined that the ttcf board was defective.After fse powering the flex vision pc back on, the issue was resolved.The system was returned to service in good working order.The codes were updated based on investigation outcome.

• 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: 24034908
• Report Number: 3003768277-2026-100127
• Device Sequence Number: 21457334
• Product Code: OWB
• UDI-Device Identifier: 00884838059115
• UDI-Public: (01)00884838059115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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 FD20/15
• Device Catalogue Number: 722058
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/05/2026; 03/05/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/10/2026; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2017
• 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