Date Initiated by Firm |
September 24, 2014 |
Create Date |
March 31, 2016 |
Recall Status1 |
Terminated 3 on March 26, 2019 |
Recall Number |
Z-1279-2016 |
Recall Event ID |
69339 |
510(K)Number |
K050151
|
Product Classification |
System, x-ray, stationary - Product Code KPR
|
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 |
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. |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
|
Manufacturer Reason for Recall |
Loss of key image functionality due to a bent pedal of the Footswitch.
|
FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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