Devices

Device Recall Powerheart AED

  • Modelo / Serial
    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; 4288698; 4288699; 4288700; 4288701; 4288702; 4288703; 4288704; 4288705; 4288706; 4288707; 4288708; 4288709; 4288710; 4288711; 4288712; 4288713; 4288714; 4288715; 4288716; 4288717; 4288718; 4288719; 4288720; 4288721; 4288722; 4288723; 4288724; 4288725; 4288726; 4288727; 4288728; 4288729; 4288730; 4288731; 4288732; 4288733; 4288734; 4288735; 4288736; 4288737; 4288738; 4288739; 4288740; 4288741; 4288742; 4288743; 4288744; 4288745; 4288746; 4288747; 4288748; 4288749; 4288750; 4288751; 4288752; 4288753; 4288754; 4288755; 4288756; 4288757; 4288758; 4288759; 4288760; 4288761; 4288762; 4288763; 4288764; 4288765; 4288766; 4288767; 4288768; 4288769; 4288770; 4288771; 4288772; 4288773; 4288774; 4288775; 4288776; 4288777; 4288778; 4288779; 4288780; 4288781; 4288782; 4288783; 4288784; 4288785; 4288786; 4288787; 4288788; 4288794; 4288795; 4288796; 4288815; 4288818; 4288819; 4288820; 4288821; 4288822; 4288823; 4288824; 4288825; 4288826; 4288827; 4288828; 4288831; 4288894; 4288895; 4288896; 4288897; 4288899; 4288900; 4288901; 4288902; 4288904; 4288905; 4288906; 4288907; 4288909; 4288912; 4288913; 4288914; 4288915; 4288916; 4288920; 4288923; 4288924; 4288925; 4288926; 4288933; 4288934; 4288951; 4288952; 4288965; 4289845; 4289846; 4289847; 4289848; 4289849; 4289850; 4289851; 4289852; 4289853; 4289854; 4289855; 4289857; 4289858; 4289862; 4289863; 4289865; 4289866; 4289867; 4289868; 4289869; 4289870; 4289871; 4289872; 4289873; 4289874; 4289902; 4289903; 4289904; 4289905; 4289978; 4289979; 4289980; 4289981; 4289982; 4289983; 4289984; 4289985; 4289986; 4289987; 4289988; 4289989; 4289990; 4289991; 4289992; 4289993; 4289994; 4289995; 4289996; 4289997; 4289999; 4290004; 4290005; 4290006; 4290007; 4290008; 4290009; 4290010; 4290011; 4290012; 4290013; 4290014; 4290015; 4290016; 4290017; 4290018; 4290019; 4290020; 4290021; 4290022; 4290023; 4290024; 4290025; 4290026; 4290027; 4290028; 4290029; 4290030; 4290031; 4290032; 4290033; 4290034; 4290035; 4290036; 4290037; 4290038; 4290039; 4290040; 4290041; 4290042; 4290043; 4290044; 4290045; 4290046; 4290047; 4290048; 4290049; 4290050; 4290051; 4290052; 4290053; 4290977; 4290978; 4290979; 4290980; 4292491; 4292492; 4292493; 4292556; 4292557; 4292558; 4292563; 4292564; 4292604; 4292605; 4292607; 4292608; 4292609; 4292610; 4292619; 4292620; 4292621; 4292663; 4292664; 4292667; 4292669; 4292682; 4292684; 4292685; 4292686; 4292688; 4292698; 4292700; 4292701; 4292704; 4292705; 4292706; 4292707; 4292708; 4292709; 4292710; 4292711; 4292712; 4292713; 4292717; 4292718; 4292719; 4292720; 4292722; 4292723; 4292725; 4292733; 4292736; 4292737; 4292738; 4292739; 4292740; 4292742; 4292743; 4292744; 4292745; 4292747; 4292748; 4292749; 4292750; 4292751; 4292752; 4292753; 4292754; 4292755; 4292760; 4292761; 4292762; 4292763; 4292764; 4292765; 4292766; 4292767; 4292768; 4292770; 4292771; 4292772; 4292773; 4292774; 4292785; 4292786; 4292787; 4292788; 4292789; 4292790; 4292791; 4292843; 4292844; 4292845; 4292846; 4292847; 4292848; 4292849; 4292851; 4292852; 4292853; 4292854; 4292855; 4292856; 4292857; 4292858; 4292859; 4292860; 4292867; 4292875; 4292878; 4292879; 4292880; 4292881; 4292882; 4292883; 4292884; 4292885; 4292893; 4292894; 4292895; 4292896; 4292898; 4292899; 4292902; 4292903; 4292904; 4292905; 4292906; 4292907; 4292908; 4292909; 4292917; 4292918; 4292926; 4292927; 4292928; 4292929; 4292930; 4292931; 4292932; 4292933; 4292934; 4292935; 4292936; 4293013; 4293029; 4293105; 4293111; 4293113; 4293114; 4293115; 4293116; 4293117; 4293118; 4293119; 4293120; 4293121; 4293122; 4293125; 4293126; 4293130; 4293131; 4293132; 4293133; 4293137; 4293138; 4293139; 4293140; 4293141; 4293142; 4293143; 4293144; 4293145; 4293146; 4293147; 4293148; 4293149; 4293150; 4293151; 4293152; 4293163; 4293165; 4293167; 4293168; 4293169; 4293170; 4293171; 4293172; 4293173; 4293176; 4296019; 4296021; 4296024; 4296031; 4296032; 4296033; 4296041; 4296043; 4296044; 4296052; 4296055; 4296074; 4296870; 4296871; 4296872; 4296873; 4296874; 4297529; 4297530; 4297547; 4297548; 4297549; 4297550; 4297551; 4297552; 4297553; 4297554; 4297555; 4297556; 4297557; 4297558; 4297559; 4297560; 4297561; 4297562; 4297563; 4297564; 4297565; 4297566; 4297567; 4297568; 4297569; 4297570; 4297571; 4297572; 4297573; 4297574; 4297590; 4297592; 4297820; 4297821; 4297822; 4297823; 4297824; 4297825; 4297826; 4297827; 4297828; 4297829; 4297830; 4297831; 4297832; 4297833; 4297835; 4297836; 4297837; 4297838; 4297839; 4297840; 4297841; 4297842; 4297843; 4297844; 4297845; 4297846; 4297847; 4297848; 4297849; 4297851; 4297854; 4297855; 4297856; 4297857; 4297858; 4297859; 4297860; 4297861; 4297862; 4297863; 4297864; 4297865; 4297866; 4297867; 4297868; 4297869; 4297870; 4297871; 4297872; 4297873; 4297874; 4297875; 4297876; 4297877; 4297878; 4297879; 4297880; 4297881; 4297882; 4297883; 4297886; 4297887; 4297888; 4297889; 4297890; 4297891; 4297892; 4297893; 4297894; 4297895; 4297896; 4297897; 4297898; 4297899; 4297900; 4297901; 4297902; 4297903; 4297904; 4297905; 4297906; 4297907; 4297908; 4297909; 4297910; 4297911; 4297912; 4297914; 4297915; 4297917; 4297918; 4297920; 4297921; 4297922; 4297923; 4297924; 4297927; 4297929; 4297930; 4297931; 4297935; 4297941; 4297942; 4297943; 4297945; 4297946; 4297947; 4297948; 4297949; 4297950; 4297951; 4297952; 4297953; 4297954; 4297955; 4297956; 4297957; 4297958; 4297959; 4297960; 4297961; 4297962; 4297963; 4297964; 4297965; 4297966; 4297967; 4297968; 4297969; 4297970; 4297971; 4297972; 4297973; 4297974; 4297975; 4297976; 4297977; 4297978; 4297979; 4297981; 4297982; 4297990; 4297991; 4297993; 4297994; 4297995; 4297997; 4297998; 4297999; 4298000; 4298001; 4298003; 4298004; 4298005; 4298012; 4298013; 4298014; 4298015; 4298016; 4298017; 4298018; 4298079; 4298214; 4298385; 4298386; 4298393; 4298394; 4298395; 4298396; 4298711; 4299008; 4299010; 4299011; 4299012; 4299013; 4299014; 4299015; 4299016; 4299017; 4299018; 4299019; 4299020; 4299021; 4299022; 4299023; 4299024; 4299025; 4299028; 4299034; 4299037; 4299038; 4299039; 4299041; 4299042; 4299043; 4299044; 4299045; 4299046; 4299047; 4299048; 4299049; 4299050; 4299051; 4299052; 4299053; 4299054; 4299055; 4299056; 4299057; 4299058; 4299185; 4299186; 4299187; 4299188; 4299189; 4299190; 4299192; 4299193; 4299194; 4299195; 4299196; 4299197; 4299198; 4299199; 4299200; 4299201; 4299203; 4299204; 4299205; 4299207; 4299208; 4299397; 4299510; 4299511; 4299512; 4299513; 4299514; 4299515; 4299517; 4299518; 4299519; 4299520; 4299521; 4299522; 4299523; 4299524; 4299525; 4299526; 4299527; 4299528; 4299529; 4299530; 4299531; 4299532; 4299533; 4299534; 4299535; 4299536; 4299537; 4299538; 4299539; 4299540; 4299542; 4299543; 4299544; 4299545; 4299546; 4299547; 4299548; 4299549; 4299550; 4299551; 4299552; 4299553; 4299554; 4299555; 4299556; 4299557; 4299558; 4299559; 4299560; 4299561; 4299562; 4299563; 4299564; 4299565; 4299566; 4299567; 4299568; 4299569; 4299570; 4299571; 4299573; 4299574; 4299575; 4299576; 4299577; 4299578; 4299579; 4299580; 4299581; 4299582; 4299583; 4299584; 4299585; 4299586; 4299587; 4299588; 4299589; 4299590; 4299591; 4299592; 4299593; 4299595; 4299596; 4299597; 4299600; 4299602; 4299603; 4299605; 4299606; 4299607; 4299608; 4299611; 4299612; 4299613; 4299614; 4299615; 4299616; 4299618; 4299619; 4299620; 4299621; 4299623; 4299624; 4299625; 4299627; 4299628; 4299629; 4299630; 4299631; 4299635; 4299636; 4299637; 4299638; 4299639; 4299640; 4299641; 4299642; 4299643; 4299644; 4299645; 4299646; 4299647; 4299649; 4299650; 4299651; 4299653; 4299654; 4299655; 4299656; 4299657; 4299658; 4299659; 4299660; 4299661; 4299662; 4299663; 4299664; 4299665; 4299666; 4299667; 4299668; 4299669; 4299670; 4299672; 4299673; 4299674; 4299675; 4299676; 4299677; 4299678; 4299679; 4299680; 4299681; 4299682; 4299683; 4299684; 4299685; 4299686; 4299687; 4299688; 4299689; 4299690; 4299691; 4299692; 4299693; 4299694; 4299695; 4299696; 4299697; 4299698; 4299699; 4299700; 4299701; 4299702; 4299703; 4299704; 4299705; 4299706; 4299707; 4299708; 4299709; 4299710; 4299711; 4299712; 4299713; 4299714; 4299715; 4299717; 4299718; 4299719; 4299721; 4299724; 4299725; 4299726; 4299727; 4299753; 4299754; 4299755; 4299756; 4299757; 4299758; 4299759; 4299760; 4299762; 4299763; 4299764; 4299774; 4299775; 4300099; 4300100; 4300101; 4300102; 4300103; 4300115; 4300116; 4300117; 4300118; and 4300119.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Cardiac Science Corporation
  • 1 Event

Fabricante

Cardiac Science Corporation
  • Dirección del fabricante
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Empresa matriz del fabricante (2017)
    Cardiac Science Corporation
  • Source
    USFDA

11 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Powerheart AED G3
  • Modelo / Serial
    Model no. 9300E serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Throughout the United States, Canada and Europe.
  • Descripción del producto
    Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.
Device Recall Powerheart AED G3
  • Modelo / Serial
    Model no. 9300A serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294.
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    Throughout the United States, Canada and Europe.
  • Descripción del producto
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.
Device Recall Powerheart AED G3
  • Modelo / Serial
    Model no. 9300P serial numbers: 900290 thru 900870
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Throughout the United States, Canada and Europe.
  • Descripción del producto
    Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.
Device Recall Powerheart AED G3
  • Modelo / Serial
    serial numbers 4000002, 4000004, 4000006, 4000007, 4000009, 4000010, 4000011, 4000013, 4000014, 4000016, 4000018, 4000019, 4000021 thru 4000024, 4000030, 4000031, 4000034, 4000040, 4000044, 4000045, 4000047, 4000048, 4000050, 4000051, 4000054, 4000057, 4000060, 4000063, 4000064, 4000065, 4000067, 4000072, 4000075, 4000079, 4000080, 4000082, 4000085, 4000086, 4000089, 4000090, 4000095, 4000097, 4000098, 4000099, 4000136, 4000138, 4000140, 4000145, 4000156, 4000162, 4000164, 4000179, 4000184, 4000186, 4000187, 4000192, 4000209, 4000215, 4000227, 4000229, 4000230, 4000232, 4000247, 4000249, 4000250, 4000255, 4000256, 4000264, 4000271, 4000274, 4000287, 4000288, 4000291, 4000295, 4000305, 4000306, 4000314, 4000322, 4000323, 4000324, 4000326, 4000330 thru 4000335, 4000337, 4000342.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    58 customers within the US: AZ, CA, CO, DC,FL, GA, Nationwide, Hungary and Singapore. IL, IN, KS, KY, LA, MI, MO, NC, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. 2 customers OUS to include: Hungary and Singapore.
  • Descripción del producto
    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science Corporation
Device Recall Powerheart AED, G2
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of AE, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, OK, EG, ES, FI, FR, GB, HK, HR, HU, 10, IE, IL, IN, IR, IS, IT, JP, KR, KW, KY, LB, LT, LV, MT, MX, NG, NL, NO, NZ, PE, PF, PL, PR, PT, QA, RO, RU, SA, SG, SK, SY, TH, TR, TT, TW, VG, ZA, and ZW.
  • Descripción del producto
    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. || The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. || The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.
  • Manufacturer
    Cardiac Science Corporation
6 más