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U.S. Department of Health and Human Services

Class 1 Device Recall Powerheart 9300D automated external defibrillator

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 Class 1 Device Recall Powerheart 9300D automated external defibrillatorsee related information
Date Initiated by FirmNovember 13, 2009
Date PostedMarch 04, 2010
Recall Status1 Terminated 3 on October 24, 2014
Recall NumberZ-0767-2010
Recall Event ID 53827
510(K)NumberK031987 K040438 K052161 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductCardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
Code Information SERIAL NUMBERS: 378784, 378785, 378786, 378787, 378788, 378789, 378790, 378791, 378792, 378793, 378794, 378795, 378796, 378797, 378798, 378799, 378800, 378801, 378802, 378803, 378804, 378805, 378806, 378807, 378808, 378809, 378810, 378811, 378812, 378813, 378814, 378815, 378816, 378817, 378818, 378819, 378820, 378821, 378822, 378823, 378824, 378825, 378826, 378827, 378828, 378829, 378830, 378831, 378832, 378833, 378834, 378835, 378836, 378837, 378838, 378839, 378840, 378841, 378842, 378843, 378844, 378845, 378846, 378847, 378848, 378849, 378850, 378851, 378852, 378853, 378854, 378855, 378856, 378857, 378858, 378859, 378860, 378861, 378862, 378863, 378864, 378865, 378866, 378867, 378868, 378869, 378870, 378871, 378872, 378873, 378874, 378875, 378876, 378877, 378878, 378879, 378880, 378881, 378882, 378883, 378984, 378985, 378986, 378987, 378988, 378989, 378990, 378991, 378992, 378993, 378994, 378995, 378996, 378997, 378998, 378999, 379000, 379001, 379002, 379003, 379004, 379005, 379006, 379007, 379008, 379009, 379010, 379011, 379012, 379013, 379014, 379015, 379016, 379017, 379018, 379019, 379020, 379021, 379022, 379023, 379024, 379025, 379026, 379027, 379028, 379029, 379030, 379031, 379032, 379033, 379034, 379035, 379036, 379037, 379038, 379039, 379040, 379041, 379042, 379043, 379044, 379045, 379046, 379047, 379048, 379049, 379050, 379051, 379052, 379053, 379054, 379055, 379056, 379057, 379058, 379059, 379060, 379061, 379062, 379063, 379064, 379065, 379066, 379067, 379068, 379069, 379070, 379071, 379072, 379073, 379074, 379075, 379076, 379077, 379078, 379079, 379080, 379081, 379082 and 379083.
Recalling Firm/
Manufacturer		 Cardiac Science Corporation
3303 Monte Villa Pkwy
Bothell WA 98021-8969
For Additional Information ContactMichael Matysik
425-402-2206
Manufacturer Reason
for Recall		Potential for devices not to deliver therapy
FDA Determined
Cause 2		Process control
ActionCardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
Quantity in Commerce181
DistributionWorldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
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
510(K)s with Product Code = MKJ
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