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

Model Number	ALLURA XPER FD10/10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's geometry computer was unable to boot, preventing geometry movements.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.The customer reported that the geo ipc failed to boot and displayed the error message ¿geometry movement partially available.¿ additional information confirmed that the event occurred outside of clinical use.As part of troubleshooting, a philips remote service engineer (rse) reviewed the system logs and determined that input power was present, however, the geo ipc did not power up.Further log analysis identified an application error indicating a loss of communication with the geo ipc, resulting in the unavailability of system movements.An onsite field service engineer (fse) inspected the system and confirmed that this was a one-time occurrence, which was resolved by restarting the system.The system was returned to service in good working conditions.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, it was identified that the issue occurred without patient involvement and was identifiable prior to procedure commencement, which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.Restart resolved the system functionality.The malfunction would not likely lead to a death or serious injury.Based on the investigation results, philips concludes that the complaint is not reportable.The investigation codes were updated based on investigation outcomes.

• 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: 24546675
• Report Number: 3042175844-2026-000114
• Device Sequence Number: 12161867
• Product Code: OWB
• UDI-Device Identifier: 00884838054196
• UDI-Public: (01)00884838054196
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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 FD10/10
• Device Catalogue Number: 722027
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2017
• 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