Class 2 Device Recall Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED

• Date Initiated by Firm: June 30, 2011
• Date Posted: September 19, 2011
• Recall Status: Terminated on February 13, 2014
• Recall Number: Z-3265-2011
• Recall Event ID: 59303
• 510(K)Number: K031987 K040438 K052161
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Cardiac Science Corporation; 3303 Monte Villa Pkwy; Bothell WA 98021-8969
• For Additional Information Contact: Cardiac Science Technical Support; 800-426-0337 Ext. 1
• Manufacturer Reason for Recall: Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro
• FDA Determined Cause: Device Design
• Action: Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail. Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly. CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED "Operator and Service Manual" provided with every AED. Customers can call Cardiac Science at 800-426-0337 or e-mail at aed205@cardiacscience.com.
• Quantity in Commerce: 195,739 units in US
• Distribution: Worldwide Distribution - US (nationwide) This action applies only to domestic
• 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; 510(K)s with Product Code = MKJ