Class 2 Device Recall Philips XRay System

• Date Initiated by Firm: February 19, 2019
• Create Date: April 13, 2019
• Recall Status: Terminated on October 14, 2020
• Recall Number: Z-1141-2019
• Recall Event ID: 82459
• 510(K)Number: K041949 K984545 K031333 K050151 K033737
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Foot Switches used with the following systems: ; 722001 Allura Xper FD 10 C; 722002 Allura Xper FD10 F; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722014 Allura Xper FD10 OR Table; 722015 Allura Xper FD20 OR Table; 722019 Allura Xper FD10/10 OR Table; 722020 Allura Xper FD20 Biplane OR Table; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722024 Allura Xper FD10/10 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722031 Allura CV20; 722033 Allura Xper FD10 OR Table; 722034 Allura Xper FD10/10 OR Table; 722035 Allura Xper FD20 OR Table; 722036 Allura Xper FD20/10 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722059 Allura Xper FD20/15 OR Table; 722123 Field extensions Xper cardio; 722124 Field extensions Xper vascular; 722126 SmartPath to upgrade Allura to AlluraClarity cardio; 722127 SmartPath to upgrade Allura to AlluraClarity vascular; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems; 722400 Cardio Vascular-Allura Centron; 722030 INTEGRIS CV; 722043 INTEGRIS Allura 15-12 (mono); ; Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
• Code Information: Foot Switches: 452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m; 452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2; 459800415531 Wireless Footswitch 3P; 459800415561 Wireless footswitch set 3P.
• Recalling Firm/ Manufacturer: Philips Medical Systems Nederlands; Veenpluis 4-6; Best Netherlands
• For Additional Information Contact: Technical Support Line; 800-7229377
• Manufacturer Reason for Recall: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
• FDA Determined Cause: Component design/selection
• Action: The firm previously notified customers on September 24, 2014 as part of Recall Z-1280-2016. On February 21, 2019, the firm sent an updated recall letter to newly identified affected consignees. Customers were alerted that bent pedal of footswitch might cause interruption of live Flouroscopy imaging or exposure. Action to be taken by Customer/User: 1. Before starting a procedure, the user should check the footswitch for possible bent pedals. If bent pedals are found the procedure should not continue and Local Service should be contacted. 2. Do not use the footswitch on an anti-fatigue mat or in the pedestal. 3. Please ensure that all staff with access to the affected systems are informed of the content of this Medical Device Correction. 4. Include this Medical Device Correction together with the documentation of the system until the system has been corrected by Philips. The firm stated that the problem will be resolved by an update of the mechanical hardware of the footswitch which will prevent the pedals of the footswitch from becoming bent. The mechanical hardware was available as of February 2019. Customers will be notified by their local Philips representative to schedule a date for installation of the mechanical hardware update. Technical Support Line: 1-800-722-9377
• Quantity in Commerce: 7209 total
• Distribution: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.; 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.