RecallDepth

Zoll AED Plus Defibrillator

Company
Zoll Medical Corporation, World Wide Headquarters
Recall Initiated
February 12, 2009
Posted
April 1, 2009
Recall Number
Z-1206-2009
Quantity
183,535 units
Firm Location
Chelmsford, MA

Reason for Recall

Device fails to discharge the defibrillation energy.

Distribution

Worldwide distribution

Lot / Code Info

Serial numbers below X_ _ _200000

Root Cause

Process design

Action Taken

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/

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