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Terminated

Zoll AED Plus Defibrillator

FDA Recall Z-1206-2009 · Posted 2009-04-01

Recalling FirmZOLL Medical Corporation, World Wide Headquarters
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-02-12
Date Terminated2026-04-09
Product Quantity183,535 units

Reason for Recall

Device fails to discharge the defibrillation energy.

Firm 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/

Root Cause

Process design

Distribution Pattern

Worldwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033474ZOLL AED PLUSZoll Medical Corp · 2004-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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