Class 2 Device Recall Powerheart AED

• Date Initiated by Firm: February 03, 2010
• Date Posted: April 06, 2010
• Recall Status: Terminated on December 08, 2011
• Recall Number: Z-1245-2010
• Recall Event ID: 54517
• 510(K)Number: K031987 K040438 K040637 K052161 K091943
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: 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).; ; Brand name: Cardiac Science.; Product name: Powerheart. ; Device Operation: Semi-automatic w/manual override.; Color: Yellow.; Voice Prompt Level: Basic.; CPR Metronome: Yes.; Rescue Ready Indicator: Yes.; Text Display: Yes.; ECG Display: Yes.
• Code Information: SERIAL NUMBERS: 4033152; 4048119; 4174711; 4290692; 4290693; 4290694; 4290695; 4290696; 4290697; 4290698; 4290699; 4290700; 4290701; 4290702; 4290703; 4290704; 4290705; 4290706; 4290707; 4290708; 4290709; 4290710; 4290711; 4290712; 4290713; 4290714; 4290715; 4290716; 4290717; 4290718; 4290719; 4290720; 4290721; 4290722; 4290723; 4290724; 4290725; 4290726; 4290727; 4290728; 4290729; 4290730; 4290731; 4290732; 4290733; 4290734; 4290735; 4290736; 4290737; 4290738; 4290739; 4290740; 4290741; 4290742; 4290743; 4290744; 4290745; 4290748; 4290751; 4290752; 4290753; 4290754; 4290755; 4290756; 4290757; 4290758; 4290759; 4290760; 4290761; 4290762; 4290763; 4290764; 4290769; 4290770; 4290771; 4290772; 4290773; 4290774; 4290775; 4290776; 4290777; 4290778; 4290779; 4290780; 4290781; 4290782; 4290783; 4290784; 4290785; 4290786; 4290787; 4290788; 4290789; 4290790; 4293293; 4293294; 4293295; 4293296; 4293297; 4293298; 4293299; 4293301; 4293302; 4293303; 4293305; 4293307; 4293308; 4293309; 4293310; 4293311; 4293312; 4293313; 4293314; 4293315; 4293329; 4293332; 4293333; 4293334; 4293337; 4293340; 4293341; 4293344; 4293345; 4293346; 4293352; 4293353; 4293354; 4293355; 4293356; 4293357; 4293358; 4293359; 4293360; 4293361; 4293362; 4293363; 4293364; 4293365; 4293366; 4293367; 4293368; 4293369; 4293370; 4293371; 4293372; 4293373; 4293374; 4293375; 4293376; 4293377; 4293378; 4293379; 4293380; 4293381; 4293382; 4293383; 4293384; 4293385; 4293386; 4293387; 4293388; 4293389; 4293390; 4293391; 4293392; 4293393; 4293394; 4293395; 4293396; 4293397; 4293398; 4293399; 4293400; 4293402; 4293404; 4293406; 4293407; 4293408; 4293409; 4293410; 4293416; 4293418; 4293420; 4293421; 4293422; 4293423; 4293424; 4293425; 4293426; 4293427; 4293428; 4293429; 4293430; 4293431; 4293432; 4293433; 4293434; 4293435; 4293436; 4293437; 4293438; 4293439; 4293440; 4293441; 4298028; 4298559; 4298561; 4298562; 4298563; 4298564; 4298566; 4298567; 4298573; 4298577; 4298578; 4298582; 4298587; 4298588; 4298589; 4298590; 4298591; 4298592; 4298593; 4298594; 4298595; 4298596; 4298597; 4298598; 4298599; 4298600; 4298601; 4298602; 4298603; 4298604; 4298606; 4298608; 4298609; 4298610; 4298611; 4298612; 4298613; 4298614; 4298615; 4298616; 4298617; 4298618; 4298619; 4298620; 4298621; 4298622; 4298623; 4298624; 4298625; 4298626; 4298627; 4298628; 4298629; 4298630; 4298631; 4298632; 4298633; 4298634; 4298635; 4298636; 4298637; 4298638; 4298639; 4298640; 4298641; 4298642; 4298643; 4298644; 4298645; 4298646; 4298647; 4298648; 4298649; 4298650; 4298651; 4298652; 4298654; 4298655; 4298680; 4298682; 4298683; 4298684; 4298685; 4298686; 4298687; 4298688; 4298689; 4298690; 4298691; 4298692; 4298693; 4298694; 4298695; 4298696; 4298697; 4298698; 4298699; 4298700; 4298701; 4298702; 4298703; 4298706; 4298707; 4298708; 4300965; 4300966; 4300967; 4300968; 4300969; 4300971; 4300972; 4300973; 4300974; 4300975; 4300976; 4300980; 4300981; 4300982; 4300988; and 902334.
• Recalling Firm/ Manufacturer: Cardiac Science Corporation; 3303 Monte Villa Pkwy; Bothell WA 98021-8969
• For Additional Information Contact: Michael Matysik; 425-402-2206
• Manufacturer 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: 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).
• Quantity in Commerce: 426
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE; 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE CORPORATION; 510(K)s with Product Code = MKJ and Original Applicant = CARDIAC SCIENCE, INC.