Class 2 Device Recall Power Heart

• Date Initiated by Firm: May 04, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on November 18, 2005
• Recall Number: Z-0990-04
• Recall Event ID: 29026
• 510(K)Number: K031987
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142
• Code Information: The recalled Model 9142 Batteries have the following lot numbers: 7848, 7849, 7850, 7853, 7854, 7855, 7857, 7858, 7859, 7860, 7861, 7863, 7866, 7867, 7868, 7870, 7871, 7872, and 7874.
• Recalling Firm/ Manufacturer: Cardiac Science, Inc.; 1900 Main Street, Suite 700; Irvine CA 92614
• For Additional Information Contact: Roderick de Greef; 949-797-3800
• Manufacturer Reason for Recall: Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
• FDA Determined Cause: Other
• Action: A recall letter, dated May 10, 2004, stated that a replacement battery is enclosed with the letter, and instructed consignees to install the new battery in their defibrilllator and return the old battery.
• Distribution: The batteries were distributed with the defibrillators nationwide in the United States and to foreign consignees in Europe, Asia, Latin America, the Middle East and Africa.
• 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