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U.S. Department of Health and Human Services

Class 1 Device Recall Zoll AED Plus

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  Class 1 Device Recall Zoll AED Plus see related information
Date Initiated by Firm February 12, 2009
Date Posted April 01, 2009
Recall Status1 Open3, 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 2
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 and Original Applicant = ZOLL MEDICAL CORP.
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