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

Model Number	ALLURA XPER FD20 OR TABLE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system had a geometry failure.The device was in 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 investigated the reported complaint.Based on the additional information collected, the procedure was completed with 20 mins of delay after transferring the patient to another room.The philips field service engineer (fse) visited the site, reviewed the system logs, and identified a "geometry cannot power on" error.During troubleshooting, the fse performed a geometry movement test, which indicated that geometry movement was unavailable.To address the issue, the fse replaced the pd.Scomp.Dcps component and returned the defective part to philips for further analysis.The supplier's analysis could not conclusively determine the root cause of the pd.Scomp.Dcps failure.However, it was noted that the component did not power on when connected to a power source.Following the replacement of the pd.Scomp.Dcps by the field service engineer, the reported issue was resolved, and the system functionality was restored.The system was subsequently verified to be operating in good working condition and was returned to clinical use.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: 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: 24219402
• Report Number: 3003768277-2026-100464
• Device Sequence Number: 8085368
• Product Code: OWB
• UDI-Device Identifier: 00884838054240
• UDI-Public: (01)00884838054240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: 722035
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• 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