Philips Medical Systems, Inc.: 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 multif

Is my product affected?

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 inte

• UPC 452270000141
• UPC 452270000151
• UPC 452270000142
• UPC 452270000381
• UPC 452270000382
• UPC 459800076001
• UPC 459800076021
• UPC 459800415571
• UPC 459800415581
• UPC 459800415531
• UPC 459800415561

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems, Inc. is recalling foot switches used with Philips MultiDiagnost Eleva equipment due to a hazard where a bent pedal can cause loss of key image functionality. A total of 168 foot switches with various product codes have been affected. The devices were distributed worldwide, including throughout the United States and to numerous countries internationally.

The specific foot switch models included in this recall are: Footswitch CV 3p 4m (codes 452270000141 and 452270000142), Footswitch MD 3p 6m (code 452270000151), Footswitch CV 3p 8m (codes 452270000381 and 452270000382), Footswitch CV 4p+2 4m and 8m (codes 459800076001 and 459800076021), Wireless Footswitch 4p+2 (code 459800415571), Wireless footswitch set 4p+2 (code 459800415581), Wireless Footswitch 3P (code 459800415531), and Wireless footswitch set 3P (code 459800415561). The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Loss of key image functionality due to a bent pedal of the Footswitch. Distribution: 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 FINLAND FRANCE GABON GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAE Quantity: 168 Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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