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