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U.S. Department of Health and Human Services

Class 2 Device Recall Philips HeartStart MRx Monitor/Defribillator

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  Class 2 Device Recall Philips HeartStart MRx Monitor/Defribillator see related information
Date Initiated by Firm February 18, 2014
Date Posted February 26, 2014
Recall Status1 Terminated 3 on February 20, 2018
Recall Number Z-1118-2014
Recall Event ID 67487
510(K)Number K051134  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart MRx Monitor/Defibrillator; Models:
M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC.

Used for the termination of ventricular tachycardia and ventricular fibrillation.
Code Information Serial numbers within the range:  US00100100 through US00550668
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Same
978-687-1501
Manufacturer Reason
for Recall		 ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal
FDA Determined
Cause 2		 Component design/selection
Action Philips Healthcare issued Urgent Medical Device Correction notification/Field Safety Notice on 2/18/14 informs customers of the issue and identifies what action Philips plans to take to remedy the issue. Philips will perform a hardware upgrade free of charge. Philips is asking customers to follow theAction to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade, while remaining aware that if the problem were to occur you could experience the following symptoms: Loss of demand mode pacing, nability to perform synchronized cardioversion with paddle andDisruption of ECG monitoring or INOP messages. Not every serial number within the listed range is affected by this Medical Device Correction. If you have questions about whether your MRx is affected by this issue, please contact Philips at 1-800-722-9377.
Quantity in Commerce 49929 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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