Powerheart 9390E 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). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
This recall has been terminated (originally issued April 6, 2010).
- Company
- Cardiac Science Corporation
- Recall Initiated
- February 3, 2010
- Posted
- April 6, 2010
- Terminated
- December 8, 2011
- Recall Number
- Z-1247-2010
- Quantity
- 1006
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Distribution
Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
Lot / Code Info
SERIAL NUMBERS: 4046748, 4171275, 4288092, 4288093, 4288094, 4288095, 4288096, 4288107, 4288108, 4288109, 4288110, 4288111, 4288112, 4288113, 4288114, 4288115, 4288116, 4288117, 4288118, 4288119, 4288155, 4288187, 4288188, 4288189, 4288190, 4288191, 4288192, 4288193, 4288194, 4288195, 4288196, 4288197, 4288198, 4288199, 4288200, 4288201, 4288202, 4288203, 4288204, 4288205, 4288206, 4288207, 4288208, 4288209, 4288281, 4288282, 4288283, 4288284, 4288285, 4288286, 4288287, 4288288, 4288289, 4288290, 4288291, 4288292, 4288293, 4288294, 4288295, 4288296, 4288305, 4288306, 4288312, 4288313, 4288314, 4288316, 4288324, 4288350, 4288351, 4288352, 4288353, 4288354, 4288355, 4288356, 4288357, 4288358, 4288359, 4288360, 4288361, 4288362, 4288363, 4288364, 4288365, 4288366, 4288367, 4288368, 4288369, 4288370, 4288371, 4288372, 4288373, 4288374, 4288375, 4288376, 4288377, 4288378, 4288379, 4288380, 4288381, 4288382, 4288383, 4288384, 4288385, 4288386, 4288387, 4288388, 4288389, 4288390, 4288391, 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4295811, 4295812, 4295813, 4295814, 4295815, 4295816, 4295817, 4295820, 4295821, 4295823, 4295824, 4295825, 4295826, 4295827, 4295828, 4295831, 4295833, 4295834, 4295835, 4295836, 4295837, 4295838, 4295839, 4295840, 4295841, 4295842, 4295868, 4295869, 4295870, 4295871, 4295872, 4295873, 4295874, 4295875, 4295876, 4295877, 4295878, 4295879, 4295880, 4295881, 4295882, 4295883, 4295884, 4295885, 4295886, 4295887, 4295888, 4295915, 4295936, 4295955, 4295956, 4295965, 4295966, 4295967, 4295968, 4295970, 4295972, 4295973, 4295974, 4295975, 4295976, 4295977, 4295978, 4295979, 4295980, 4295981, 4295982, 4295983, 4295984, 4295985, 4295986, 4295987, 4295988, 4295989, 4295990, 4295991, 4295992, 4295993, 4295994, 4295995, 4295996, 4295997, 4295998, 4295999, 4296000, 4296002, 4296003, 4296004, 4296005, 4296008, 4296009, 4296010, 4296012, 4296013, 4296014, 4296015, 4296016, 4296017, 4296018, 4297019, 4297020, 4297021, 4297022, 4297023, 4297024, 4297027, 4297028, 4297029, 4297030, 4297031, 4297032, 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4300381, 4300382, 4300384, 4300385, 4300386, 4300387, 4300388, 4300389, AND 4300723.
Root Cause
Nonconforming Material/Component
Action Taken
The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).