Recall Z-1243-2010
Cardiac Science Corporation · initiated February 3, 2010
Product
Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Codes / lots: SERIAL NUMBERS: 390599; 4027917; 4045272; 4045316; 4045329; 4045370; 4045379; 4117863; 4117907; 4118157; 4146718; 4146719; 4146721; 4146722; 4146726; 4146727; 4146729; 4146734; 4146744; 4146746; 4146751; 4146754; 4146759; 4154527; 4165042; 4166087; 4180911; 4180941; 4184166; 4184195; 4184246; 4189978; 4256127; 4256983; 4261787; 4263875; 4269480; 4269483; 4269484; 4269485; 4288023; 4288024; 4288025; 4288026; 4288030; 4288032; 4288035; 4288036; 4288037; 4288048; 4288049; 4288051; 4288052; 4288616; 4288617; 4288618; 4288619; 4288620; 4288621; 4288622; 4288623; 4288624; 4288625; 4288626; 4288627; 4288628; 4288629; 4288630; 4288631; 4288632; 4288633; 4288634; 4288635; 4288636; 4288637; 4288638; 4288639; 4288640; 4288641; 4288642; 4288643; 4288644; 4288649; 4288650; 4288651; 4288652; 4288653; 4288654; 4288655; 4288656; 4288657; 4288658; 4288659; 4288660; 4288661; 4288662; 4288663; 4288664; 4288665; 4288666; 4288667; 4288668; 4288669; 4288670; 4288671; 4288672; 4288673; 4288674; 4288675; 4288676; 4288677; 4288678; 4288679; 4288680; 4288681; 4288682; 4288683; 4288684; 4288685; 4288686; 4288687; 4288688; 4288689; 4288690; 4288691; 4288692; 4288693; 4288694; 4288695; 4288696; 4288697…
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.
FDA-determined 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).
Details
- Recall number
- Z-1243-2010
- Initiated
- February 3, 2010
- Posted by FDA
- April 6, 2010
- Terminated
- December 8, 2011
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 1162
- 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…
- Recalling firm
- Cardiac Science Corporation, Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1244-2010 | Powerheart 9300E automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1245-2010 | Powerheart 9300P automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1246-2010 | Powerheart 9390A automated external defibrillator. This fully automatic model does not…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1247-2010 | Powerheart 9390E automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1248-2010 | Responder 2023440 automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |
| Z-1249-2010 | Cardiovive 92532 automated external defibrillator. This semi-automatic model requires…A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver… | 02/03/2010Terminated |