Class 1 Device Recall Zoll AED Plus

• Date Initiated by Firm: February 12, 2009
• Date Posted: April 01, 2009
• Recall Status: Open, Classified
• Recall Number: Z-1206-2009
• Recall Event ID: 51053
• 510(K)Number: K033474
• Product Classification: automated external defibrillator - Product Code MKJ
• Product: Zoll AED Plus Defibrillator
• Code Information: Serial numbers below X_ _ _200000
• Recalling Firm/ Manufacturer: ZOLL Medical Corporation, World Wide Headquarters; 269 Mill Rd; Chelmsford MA 01824
• For Additional Information Contact: 978-421-9655 Ext. 413
• Manufacturer Reason for Recall: Device fails to discharge the defibrillation energy.
• FDA Determined Cause: Process design
• Action: On 3/31/09, the firm revised their recall strategy and required all users to a perform a "Mandatory Upgrade" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009. In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update their devices with software that will monitor batteries for the identified defect. ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/
• Quantity in Commerce: 183,535 units
• Distribution: Worldwide distribution
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MKJ