Recall StatusTerminated
Date Initiated2008-12-30
Date Terminated2011-11-21
Product Quantity23,467 units worldwide
Reason for Recall
When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.
Firm Action
Physio Control sent a " Urgent Medial Device Safety Alert" letter dated January 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer.
The letter instructed the customers to follow the Operating Instructions for AED and Manual Defibrillation mode (Section 4-Therapy, pages 58 and 61) that instructs users to "Connect therapy electrodes to the therapy cable and confirm cable connection to the defibrillator" to prevent users from mistakenly leaving the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.
Recommendations to users who use a Therapy Cable:
-Disconnect the QUIK-COMBO test plug prior to patient use
-Confirm therapy electrodes - to - therapy cable connection
-Confirm therapy cable - to - defibrillator connection
-Confirm therapy electrodes - to - patient connection
Adding 2005 American Heart Association software that includes audible and visual prompts to LIFEPAK 20 defibrillators manufactured prior to January 2007 is optional and not required. If the customers would like to have this optional kit installed in your defibrillators, please contact Physio Control, Inc.
Customers can call Technical Support at 1-800-442-1142 for any questions about this recall or or visit our website at www.physio-control
notices.com/LP20testplug.
Distribution Pattern
Worldwide Distribution--USA ( nationwide ) and the countries of Bahrain, Lebanon , Cyprus, Netherlands, Egypt, Pakistan, Germany, Saudi Arabia, India, South Africa, Iran, Syria, Israel, Turkey, Jordan, UAE,Kuwait,
Yemen, Asia Pacific, Australia, New Caledonia, Guam, New Zealand, Hong Kong, Latin America, Anguilla, Jamaica, Argentina, Mexico, Bahamas, Nicaragua, Brazil, Panama, Chile, Peru, Colombia, Trinidad, Costa Rica,
Uruguay, El Salvador, Venezuela, Guatemala, Virgin Islands and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.