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U.S. Department of Health and Human Services

Class 1 Device Recall Philps HeartStart MRx Monitor/Defibrillator

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  Class 1 Device Recall Philps HeartStart MRx Monitor/Defibrillator see related information
Date Initiated by Firm February 24, 2017
Create Date March 24, 2017
Recall Status1 Open3, Classified
Recall Number Z-1417-2017
Recall Event ID 76545
510(K)Number K031187  K040404  K051134  K061707  K062233  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartStart MRx Monitor/Defibrillator,
Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Code Information Model# Serial Numbers, M3535A US00100100 to US00602546, M3535ATZ US00100100 to US00602546, M3536A US00100902 to US00602540, (M3536ATZ) US00100902 to US00602540, M3536M US00500002 to US00553553, M3536MC US00500001 to US00500087, M3536M2 US00554176 to US00554178, M3536M3 US00571854 to US00588995, M3536M4 US00500003 to US00590982, M3536M5 US00500001 to US00587771, M3536M6 US00554358 to US00600582, M3536M7 US00581047 to US00601962, M3536M8 US00590958 to US0059095, M3536M9 US00581048 to US00581049.
Recalling Firm/
Manufacturer
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Kerry Chase
978-659-2978
Manufacturer Reason
for Recall
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
FDA Determined
Cause 2
Device Design
Action Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice. on 2/24/17. The Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Action (1) Philips is voluntarily initiating this correction and is providing Instructions for Use (IFU) Addendum titled, HeartStart MRx Battery Connector Pins for all customers with affected units. 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: Philips is asking the customer when inspecting the device, to inspect the HeartStart MRx battery compartment connections. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue. Action (2) Philips is voluntarily initiating this correction and is providing measures to prevent, or methods to allow the user to correct, the abnormal device behavior related to charging and pacing after disconnecting the device from AC mains.
Quantity in Commerce 97,794 total ( 47,362 US and 50,429 OUS)
Distribution Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, 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, DOMINICAN REPUBLIC,ECUADOR,EGYPT,EL SALVADOR, ESTONIA, ETHIOPIA,FINLAND,FRANCE,GABON,GERMANY,GHANA,GREECE, GUADELOUPE, HONG KONG,HUNGARY,ICELAND,INDIA, INDONESIA,IRAN (ISLAMIC REPUBLIC OF),IRAQ,IRELAND,ISRAEL,ITALY,JAPAN, JORDAN, KAZAKHSTAN, KENYA,KOREA, REPUBLIC OF,KUWAIT,LAOS,LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA,LITHUANIA,LUXEMBOURG, MACAU, MACEDONIA,MALAYSIA,MALTA,MAURITIUS,MEXICO,MONGOLIA, MOROCCO, MOZAMBIQUE,MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES,NEW CALEDONIA,NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA,PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL,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

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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