Class 1 Device Recall Powerheart 9300P automated external defibrillator

• Date Initiated by Firm: November 13, 2009
• Date Posted: March 04, 2010
• Recall Status: Terminated on October 24, 2014
• Recall Number: Z-0769-2010
• Recall Event ID: 53827
• 510(K)Number: K031987 K040438 K052161
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Cardiac Science 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).; ; Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.
• Code Information: SERIAL NUMBERS: 391776, 393102, 402793, 404926, 900002, 900003, 900004, 900005, 900006, 900007, 900008, 900009, 900010, 900011, 900012, 900013, 900014, 900015, 900016, 900017, 900018, 900019, 900020, 900021, 900022, 900023, 900024, 900025, 900026, 900027, 900028, 900029, 900030, 900035, 900036, 900037, 900038, 900039, 900040, 900041, 900042, 900044, 900045, 900046, 900047, 900048, 900049, 900050, 900051, 900052, 900053, 900054, 900055, 900056, 900057, 900058, 900059, 900060, 900062, 900063, 900064, 900065, 900066, 900067, 900068, 900069, 900070, 900071, 900072, 900073, 900075, 900076, 900077, 900078, 900079, 900080, 900081, 900082, 900083, 900084, 900085, 900086, 900087, 900088, 900089, 900090, 900091, 900092, 900093, 900094, 900096, 900097, 900099, 900100, 900102, 900103, 900104, 900105, 900106, 900107, 900108, 900109, 900121, 900123, 900124, 900126, 900127, 900128, 900129, 900131, 900132, 900133, 900134, 900135, 900136, 900138, 900139, 900140, 900142, 900143, 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• 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: Potential for devices not to deliver therapy
• FDA Determined Cause: Process control
• Action: Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures. For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
• Quantity in Commerce: 8488
• Distribution: Worldwide Distribution -- UNITED STATES, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GRECE, GUAM, GUATEMALA, HOLLAND, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONACO, MORROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SCOTLAND, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, VIRGIN ISLANDS AND YEMEN.
• 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, INC.