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U.S. Department of Health and Human Services

Class 2 Device Recall Power Heart

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 Class 2 Device Recall Power Heartsee related information
Date Initiated by FirmMay 24, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 18, 2005
Recall NumberZ-1034-04
Recall Event ID 29024
510(K)NumberK011901 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
ProductPower Heart Automatic External Defibrillator, Model 9210 RD
Code Information Serial Numbers of the recalled Model 9200 RD and Model 9210 RD AEDs are: 300122,300226, 300450, 300672, 300855, 301848, 303845, 304550, 305544, 306004, 306420, 306426, 306474, 306500, 306572, 306585, 306586, 306615, 306663, 306685, 306691 through 306810, 307433, 308131 through 308530, 308839, 309180, 309218, 309236, 309426, 309438, 309561, 309691 through 309894, 309897, 309903 through 309908, 309913, 309915, 309917, 309922, 309924, 309929, 309930, 309944, 309959, 309971 through 310170, 310181, 310411 through 310490, 310571 through 310610, 310691 through 311170, 311211 through 312170, 312211 through 312290, 312651 through 316050, 316518, 316691 through 316730, 316853, 316862, 316949, 316961, 316964, 316973, 317056, 317058, 317106, 317123, 317131, 317180, 317183, 317185, 317189, 317191, 317207, 317266, 317270, 317278, 318171 ¿ 318190, 318211 through 318330, 318347, 318371 through 318410, 318419, 318424, 318427, 318433, 318435, 318439, 318446, 320691 through 320930, and the following individual serial numbers separated by commas: 268231-02-35, 74414-1602, 74414-0213, 74777-0802, 75180-0246, 75180-0189, 75180-0088, 75180-0045, 75180-0608, 75180-0241, 75180-0083, 75180-0059, 75180-0123, 75180-0097, 75180-0040, 75180-0103, 75180-0109, 75180-0096, 75180-0060, 75180-0090, 75180-0091, 75180-0114, 75180-0100, 75180-0046, 75180-0047, 75180-1866, 75180-0111, 75180-0048, 75180-0085, 75180-0057, 75180-0073, 75180-0113, 75180-0237, 75180-0086, 75180-0239, 75180-0225, 75180-0606, 75180-0226, 75180-0980, 75180-0099, 75180-0061, 75180-0041, 75180-0112, 75180-0094, 75180-0076, 75180-0107, 75180-0002, 75180-1000, 75180-0049, 75180-0101, 75180-0079, 75180-0400, 75180-0607, 75180-0102, 75180-0058, 75180-0106, 75180-0062, 75180-0120, 75180-0069, 75180-0082, 75180-0072, 75180-0039, 75180-0121, 75180-0071, 75180-0074, 75180-0117l, 75180-0037, 75180-0240, 75180-0119, 75180-0063, 75180-0050, 75180-0238, 75180-0108, 75180-0093, 75180-0077, 75180-0087, 75180-0236, 75180-0067, 75180-0065, 75180-0056, 75180-0095, 75180-0105, 75180-0110, 75180-0044, 75180-0122, 75180-0115, 75180-0092, 75180-0075, 75180-0068, 75180-0084, 75180-0104, 75180-0080, 75180-0098, 75180-0118, 75180-0116, 75180-0244, 75180-0081, 75180-0078, 75180-0070, 75180-0042, 75180-0089, 75180-0064, and 75180-0043
FEI Number 2112020
Recalling Firm/
Manufacturer		 Cardiac Science, Inc.
5474 Feltl Rd.
Minneapolis MN 55343-7982
For Additional Information ContactRoderick de Greef
949-797-3800
Manufacturer Reason
for Recall		Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
FDA Determined
Cause 2		Other
ActionA recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.
DistributionThe recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = MKJ
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