FDAFebruary 19, 2019device

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 mini...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems nederlandsphilipsphilips medical

UPCs

452270000141452270000151452270000142452270000381452270000382459800076001459800076021459800415571459800415581459800415531459800415561

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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