Philips Medical Systems, Inc. recalls Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips Mult…

Recall date

September 24, 2014

Source

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

Recall number

Z-1279-2016

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RICA CROATIA CUBA CZECHOSLOVAKIA DENMARK DOMINICAN REPUB ECUADOR EGYPT ESTONIA…

Why it was recalled

Loss of key image functionality due to a bent pedal of the Footswitch.

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 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography