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

Model Number	ALLURA XPER FD10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's host computer was unable to boot, preventing a full system boot.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 has investigated this complaint.According to the additional information collected, the system was not in clinical use when the issue occurred.The philips remote service engineer (rse) inspected the system remotely and confirmed that the host pc was not booting up.Upon troubleshooting, the rse stated that the host pc has low cmos battery.The rse instructed the customer to turn the pc manually and restart, after which the system became operational.To resolve the issue completely, in another case the cmos battery was replaced.After functional tests, the system was returned to use in good working condition.The philips has initiated medical device correction (2024-igt-bst-017) for the cmos battery malfunction.The codes were updated based on the investigation outcome.The evaluation method code was corrected.

• 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: 24800525
• Report Number: 3042175844-2026-000438
• Device Sequence Number: 9548280
• Product Code: OWB
• UDI-Device Identifier: 00884838054189
• UDI-Public: (01)00884838054189
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 FD10
• Device Catalogue Number: 722026
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0002-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown