CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report

Foot Switches used with Philips MultiDiagnost Eleva recalled

Philips Medical Systems is recalling Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector, distributed nationwide in the US. The recall was initiated on 24 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFoot 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.

Quantity recalled168

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1279-2016
FDA event ID: 69339
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 24 Sep 2014
FDA classified: 31 Mar 2016
Reported: 6 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

24 Sep 2014	Recall initiated by company
31 Mar 2016	Classified by FDA	+554 days
6 Apr 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was 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 FINLAND FRANCE GABON GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA SOUTH KUWAIT LATVIA LEBANON LIBYA LITHUANIA MACEDONIA MALAYSIA MAURITIUS MEXICO MOLDAVIA MONGOLIA MOROCCO NEPAL NETHERLANDS NETHERLANDS ANT NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PANAMA Papua New Guinea PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUORTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERAT SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TANZANIA THAILAND TUNISIA TURKEY UKRAINE UNITED ARAB EMI United Arab Emirates UNITED KINGDOM URUGUAY USA UZBEKISTAN VENEZUELA VIETNAM YEMEN GUADELOUPE SYRIAN ARAB REPUBLIC

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 69339

Reported	Class	Recall	Company	Reason	Where
6 Apr 2016	CLASS II	Foot Switches used with the following systems recalled	Philips Medical Systems	Other	Nationwide

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