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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 automatic external defibrillator.
Recall Number Z-1439-2014
Classification Class II
Code Info Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269
Product Distributed Qty 19 units
Reason For Recall A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy

Event Detail

Event Id 67857
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 2014-03-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.