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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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
Recall Number Z-1194-2014
Classification Class II
Code Info MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
Product Distributed Qty 6583 units
Reason For Recall When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.

Event Detail

Event Id 67459
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems, Inc.
City Andover
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
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