Recall Z-0769-2010
Cardiac Science Corporation · initiated November 13, 2009
Product
Cardiac Science Powerheart 9300P 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.
Codes / lots: SERIAL NUMBERS: 391776, 393102, 402793, 404926, 900002, 900003, 900004, 900005, 900006, 900007, 900008, 900009, 900010, 900011, 900012, 900013, 900014, 900015, 900016, 900017, 900018, 900019, 900020, 900021, 900022, 900023, 900024, 900025, 900026, 900027, 900028, 900029, 900030, 900035, 900036, 900037, 900038, 900039, 900040, 900041, 900042, 900044, 900045, 900046, 900047, 900048, 900049, 900050, 900051, 900052, 900053, 900054, 900055, 900056, 900057, 900058, 900059, 900060, 900062, 900063, 900064, 900065, 900066, 900067, 900068, 900069, 900070, 900071, 900072, 900073, 900075, 900076, 900077, 900078, 900079, 900080, 900081, 900082, 900083, 900084, 900085, 900086, 900087, 900088, 900089, 900090, 900091, 900092, 900093, 900094, 900096, 900097, 900099, 900100, 900102, 900103, 900104, 900105, 900106, 900107, 900108, 900109, 900121, 900123, 900124, 900126, 900127, 900128, 900129, 900131, 900132, 900133, 900134, 900135, 900136, 900138, 900139, 900140, 900142, 900143, 900144, 900145, 900146, 900147, 900148, 900149, 900150, 900151, 900152, 900153, 900154, 900156, 900158, 900159, 900160, 900161, 900162, 900165, 900166, 900168, 900169, 900170, 900172, 900173, 900174, 900176, 900177…
Reason for recall
Potential for devices not to deliver therapy
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0769-2010
- Initiated
- November 13, 2009
- Posted by FDA
- March 4, 2010
- Terminated
- October 24, 2014
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 8488
- 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…
- Recalling firm
- Cardiac Science Corporation, Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0765-2010 | Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0766-2010 | Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0767-2010 | Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0768-2010 | Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0770-2010 | Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0771-2010 | Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0772-2010 | Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0773-2010 | Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0774-2010 | Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0775-2010 | GE Responder 2019198 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0776-2010 | GE Responder 2023440 automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0777-2010 | NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires…Potential for devices not to deliver therapy | 11/13/2009Terminated |
| Z-0778-2010 | NK 9200G. CardioLife automated external defibrillator. This semi-automatic model…Potential for devices not to deliver therapy | 11/13/2009Terminated |