Class 2 Device Recall Philips HeartStart MRx monitor/defibrillators

• Date Initiated by Firm: June 20, 2012
• Date Posted: September 10, 2012
• Recall Status: Terminated on February 15, 2017
• Recall Number: Z-2347-2012
• Recall Event ID: 62328
• 510(K)Number: K051134
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, 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: Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments, distributed worldwide
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips Healthcare Inc.; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: 978-687-1501
• Manufacturer Reason for Recall: Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
• FDA Determined Cause: Equipment maintenance
• Action: Philips notified customers on June 20, 2012, by an Urgent Medical Device Correction notification/Field Safety Notice and a revised Instructions for Use addendum for each HeartStart MRx unit. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of units affected and and identifies the action. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Carefully read the attached HeartStart MRx Instructions for Use Addendum. Immediately implement ongoing therapy connection inspection on all of your MRx devices to detect wear from higher than expected levels of stress. The HeartStart MRx Instructions for Use Addendum describes how a user can identify wear. If wear is detected, remove affected devices immediately from use and contact Philips to arrange for service. WARNING: The service life of your therapy cables/external paddles is up to three years. To maintain reliable performance and reduce the possibility of failure during patient use, replace them every three years from the time they were initially placed into service or if they fail the inspection criteria in the attached Instructions for Use Addendum The addendum provides the customer with complete user information regarding ongoing inspections of port. In addition, service support will be provided for Therapy Port and Cables requirement replacements. Further information or support concerning this issue,contact your local Philips representative at 1-800-722-9377. For questions regarding this recall calll 978-687-1501.
• Quantity in Commerce: 58,701 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 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 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 PARAGUAY 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