Date Initiated by Firm |
April 10, 2013 |
Date Posted |
December 31, 2013 |
Recall Status1 |
Terminated 3 on April 13, 2017 |
Recall Number |
Z-0613-2014 |
Recall Event ID |
67035 |
510(K)Number |
K051134
|
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
|
Product |
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician |
Code Information |
Serial numbers ranging: From US00100100 to US00210461 |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
978-687-1501
|
Manufacturer Reason for Recall |
Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and
|
FDA Determined Cause 2 |
Environmental control |
Action |
Philips issued a Medical Device Correction letter April 2013 to all affected customers along with an IFU Addendum titled, HeartStart MRx Electromagnetic Compatibility. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the condition could be avoided by operating the device on external AC or external DC power. Customers were instructed to follow the device instructions when using battery power to minimize or eliminate potential interference from other RF sources. Customers with questions were instructed to contact their local Philips representative.
For questions regarding this recall call 978-687-1501. |
Quantity in Commerce |
64,972 |
Distribution |
Worldwide Distribution - USA (nationwide) and Internationally to the following countries:
AFGHANISTAN
ALBANIA
ARGENTINA
ARUBA
AUSTRALIA
AUSTRIA
AZERBAIJAN
BAHRAIN
BANGLADESH
BELGIUM
BOLIVIA
BOSNIA AND HERZEGOWINA
BRAZIL
BRUNEI DARUSSALAM
BULGARIA
CAMBODIA
CANADA
CHILE
CHINA
COLOMBIA
COSTA RICA
CROATIA (local name: Hrvatska)
CYPRUS
CZECH REPUBLIC
DENMARK
ECUADOR
EGYPT
EL SALVADOR
ESTONIA
ETHIOPIA
FINLAND
FRANCE
GERMANY
GREECE
GUADELOUPE
HONG KONG
ICELAND
INDIA
INDONESIA
IRAQ
IRELAND
ISRAEL
ITALY
JAPAN
JORDAN
KAZAKHSTAN
KENYA
KOREA, REPUBLIC OF
KUWAIT
LAOS
LATVIA
LEBANON
LIBYAN ARAB JAMAHIRIYA
LITHUANIA
LUXEMBOURG
MACAU
MACEDONIA
MALAYSIA
MALTA
MEXICO
MONGOLIA
MOROCCO
NAMIBIA
NEPAL
NETHERLANDS
NETHERLANDS ANTILLES
NEW CALEDONIA
NEW ZEALAND
NICARAGUA
NIGERIA
NORWAY
OMAN
PAKISTAN
PALESTINE
PANAMA
PAPUA NEW GUINEA
PARAGUAY
PERU
PHILIPPINES
POLAND
PORTUGAL
PUERTO RICO
QATAR
REUNION
ROMANIA
RUSSIAN FEDERATION
SAUDI ARABIA
SERBIA
SINGAPORE
SLOVENIA
SOUTH AFRICA
SPAIN
SRI LANKA
SWEDEN
SWITZERLAND
TAIWAN, PROVINCE OF CHINA
TANZANIA, UNITED REPUBLIC OF
THAILAND
TRINIDAD AND TOBAGO
TUNISIA
TURKEY
TURKMENISTAN
UGANDA
UKRAINE
UNITED ARAB EMIRATES
UNITED KINGDOM
UZBEKISTAN
VENEZUELA
VIET NAM
YEMEN |
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 = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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