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

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	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system gave a remote alert indicating the "flexmove xy y motor current margin exceeded", preventing geometry movements.The device was in clinical 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 has investigated this complaint.According to the additional information collected, the planned treatment procedure was being performed when the issue occurred and was completed as planned, as the customer did not notice any issue with system, the system functioned normally, the philips received an alert indicating flexmove xy y motor current margin exceeded.The philips field service engineer (fse) visited system onsite and found the errors that the y axis motorized movement stops abruptly, followed by a slight reverse motion, in the logs.However, upon troubleshooting fse could not find any mechanical faults, and the issue could not be reproduced during testing.As a preventive measure, the fse performed current calibration of the x and y movements of the flexmove and performed functional tests and the system was confirmed to be operating as intended.At the time this complaint was received, philips did not have enough information to exclude a product malfunction with the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received 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.The reported issue did not impact the completion of the procedure.The procedure was completed as planned on the same system, with no impact on completion of procedure, patient or user.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.

• Brand Name: ALLURA XPER FD
• Common Device Name: SYSTEM, X-RAY, ANGIOGRAPHIC
• 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: 23960393
• Report Number: 3003768277-2026-100005
• Device Sequence Number: 5611883
• Product Code: IZI
• UDI-Device Identifier: 00884838059085
• UDI-Public: (01)00884838059085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130842
• 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): 03/17/2026

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: 722023
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2013
• 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