The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. The LIFEPAK 500 AED is intended for use in the pre-hospital and workplace and community environments. It has been tested to RTCA/DO-160D; "Environmental Conditions and Test Procedures for Airborne Equipment" (refer to Specifications on page 5-15 of the Operating Instructions 3005338-001). The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: -CPR training -AED training equivalent to that recommended by the American Heart Association -Training in the use of the LIFEPAK 500 AED.
FDA Recall Z-2885-2011 · Posted 2011-07-26
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Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2011-06-06
Date Terminated2012-02-23
Product Quantity12197 units distributed worldwide (5169 units outside US; 7028 units in the US)
Reason for Recall
The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access
Memory) electronic component on the main printed circuit board assembly.
Firm Action
Physio-Control, Inc. sent an "URGENT- ACTION REQUIRED" letter dated June 2011 to all affected customers. The letter describes the product, problem, and the action to be taken by the customer.
The letter recommends that users who store their device(s) in hard-shelled carrying cases remove them from the case(s)immediately and discontinue the use of the case(s). Additionally, the letter recommends that customers perform regular maintenance in accordance with the Operating Instructions. A Confirmation Sheet was enclosed with the letter for customers to complete and return via fax at 1-866-448-9567.
Customers can call the Technical Support Team at 1-800-442-1142, Option 5.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Bahamas, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Iran, Japan, Mexico, Netherlands, Peru, and Uruguay.
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.
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