Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 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.

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.

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