—#207941

Product

Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K162859
Affected lot / code info: Product number: 722013, UDI/DI: 00884838059061; Serial Number: 232.

Why it was recalled

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On May 14, 2024 URGENT Medical Device Correction letters were sent to consignees. Actions that should be taken by the customer / user to lower risks for patients: " Circulate this Urgent Medical Device Correction letter to all users so that they are aware of the issue. " Philips recommends discontinuing use of the system for procedures that can be safely postponed to another time, or for procedures that can be performed with another system. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Medical Device Correction letter and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGT-S to correct the issue: Philips will be re-installing the previous software release in all affected systems. Philips will contact affected customers immediately to schedule a visit to perform this software change (reference FCO72200588). If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: Domestic: OK International: India, Spain, U.A.E.

Timeline

Recall initiated: 2024-05-16
Posted by FDA: 2024-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.