Cardiac Science Corporation: Cardiac 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.

Recall number

Z-0767-2010

Recalling firm

Cardiac Science Corporation

Product

Cardiac 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.

Status

Terminated

Initiated

2009-11-13

Posted

2010-03-04

Terminated

2014-10-24

Reason

Potential for devices not to deliver therapy

Root cause

Process control

Action

Cardiac 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

181

Distribution

Worldwide 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.

Lot, serial or model codes

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.

510(k) numbers

["K031987","K040438","K052161"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

2112020

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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