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U.S. Department of Health and Human Services

Class 2 Device Recall Powerheart AED G3

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  Class 2 Device Recall Powerheart AED G3 see related information
Date Initiated by Firm November 12, 2004
Date Posted January 15, 2005
Recall Status1 Terminated 3 on June 25, 2006
Recall Number Z-0399-05
Recall Event ID 30704
510(K)Number K040438  
Product Classification unknown device name - Product Code NPN
Product Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
Code Information Model no. 9300A serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294.
Recalling Firm/
Manufacturer		 Cardiac Science, Inc.
5474 Feltl Rd
Minnetonka MN 55343-7982
For Additional Information Contact Mac McKeen
952-939-2911
Manufacturer Reason
for Recall		 AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.
Quantity in Commerce 581
Distribution Throughout the United States, Canada and Europe.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NPN and Original Applicant = CARDIAC SCIENCE, INC.
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