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Recall Observatory FDA recall evidence

Device product

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

Z-1279-2016

September 24, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 69339
Status
Terminated
Classification
Class II
Quantity
168
Official record key
device-enforcement:Z-1279-2016

Official wording

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

Code information: 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.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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