Cardiac Science Corporation

Serial Numbers:  3201281, 3201806, 3201810, 3201815, 3202223, 3202233, 3202244, 3202248, 3202249, 3202253, 3202255, 3202256, 3202257, 3202260, 3202262, 3202269, 3202271, 3202273, 3202275, 3202280, 3202281, 3202283, 3202284, 3202285, 3202286, 3202287, 3202288, 3202290, 3202291, 3202292, 3202297, 3202299, 3202300, 3202301, 3202303, 3202304, 3202305, 3202306, 3202308, 3202310, 3202311, 3202312, 3202313, 3202315, 3202316, 3202317, 3202319, 3202321, 3202324, 3202327, 3202328, 3202331, 3202332, 3202333, 3202334, 3202336, 3202337, 3202338, 3202339, 3202340, 3202344, 3202347, 3202348, 3202349, 3202350, 3202351, 3202352, 3202354, 3202355, 3202356, 3202357, 3202358, 3202360, 3202361, 3202362, 3202363, 3202364, 3202365, 3202371, 3202377, 3202379, 3202380, 3202381, 3202382, 3202385, 3202386, 3202387, 3202388, 3202389, 3202390, 3202391, 3202392, 3202393, 3202394, 3202395, 3202396, 3202397, 3202398, 3202399, 3202400, 3202401, 3202403, 3202404, 3202405, 3202406, 3202407, 3202408, 3202409, 3202411, 3202412, 3202414, 3202415, 3202416, 3202417, 3202418, 3202419, 3202420, 3202421, 3202422, 3202423, 3202427, 3202429, 3202439, 3202442, 3202443, 3202444, 3202447, 3202448, 3202450, and 3202451.

Cardiovascular Devices

3

No

Worldwide Distribution: Throughout the US, and in the countries of Germany, Korea, Peru, Singapore, and Spain.

GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare.

Cardiovascular Devices

3

No

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.

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.

Serial numbers: 022805, 031605, 303024, 322627, 322644, 328877, 900034, 900055, 900061, 900110, and 972196. Serial numbers Ranges:  from 900134 through 903240;  from 329024 through 394573; from 400001 through 4049272;  from 4100002 through 4370573;  from 92532-0000501 through 92532-0001310; and from 92533-0000000 through 92533-0001340.

Cardiovascular Devices

3

No

Worldwide Distribution - US (nationwide) This action applies only to domestic

Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. || Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. || Brand names: Powerheart AED, G3, CardioVive AED, GE Responder || AED, Nihon Kohden CardioLife AED.

Cardiovascular Devices

3

No

Worldwide distribution: USA (nationwide) and Puerto Rico; and to the following countries: Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Malaysia, Maldives, Malta, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saint Lucia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, Ukraine, and United Kingdom.

Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. || The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or other physician-authorized medical response.

Lot Numbers: W029275 and W029476.

Cardiovascular Devices

3

No

Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.

9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.