Philips Medical Systems Nederlands recalls Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allur…

Recall date

February 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1140-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems Nederlands

Sold / distributed

US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.