Z-1279-2016Class II

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This...

Name: Z-1279-2016 Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This...
Creator: Philips Medical Systems, Inc.
Published: 2014-09-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-09-24 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used... on 2014-09-24. FDA classified it as Class II and gives the reason as "Loss of key image functionality due to a bent pedal of the Footswitch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1279-2016
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Posted: 2016-03-31
Terminated: 2019-03-26
Recalling firm: Philips North America LLC
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
Product code: KPR System, X-Ray, Stationary
Reason for recall: Loss of key image functionality due to a bent pedal of the Footswitch.
Root cause tag: design
FDA root cause: Device Design
Action: Field Safety Noticed was mailed on September 24, 2014 via Certified Return Receipt. This FCC consists of a Mechanical Hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoro images or exposures. Customers with questions were instructed to contact their local Philips representative.
Quantity in commerce: 168
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 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1279-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1279-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1280-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

Product code KPR

K050151Class IIMultidiagnost ElevaPhilips Medical Systems North America, Inc. / cleared 2005-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)