Z-0767-2010

Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the...

Name: Z-0767-2010 Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the...
Creator: Cardiac Science Corporation
Published: 2009-11-13
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2009-11-13 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science Corporation began a recall of Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device... on 2009-11-13. The reason FDA records is "Potential for devices not to deliver therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0767-2010
Status: Terminated
Initiated: 2009-11-13
Posted: 2010-03-04
Terminated: 2014-10-24
Recalling firm: ZOLL Medical 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Potential for devices not to deliver therapy
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)