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U.S. Department of Health and Human Services

Class 1 Device Recall AED 10

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  Class 1 Device Recall AED 10 see related information
Date Initiated by Firm December 15, 2008
Date Posted March 10, 2009
Recall Status1 Terminated 3 on March 19, 2012
Recall Number Z-1007-2009
Recall Event ID 50532
510(K)Number K021168  
Product Classification automated external defibrillator - Product Code MKJ
Product Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Code Information Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall
Recalling Firm/
Welch Allyn Protocol, Inc
8500 Sw Creekside Pl
Beaverton OR 97008
For Additional Information Contact
Manufacturer Reason
for Recall
Potential for device to deliver less than the programmed energy.
FDA Determined
Cause 2
Process control
Action Welch Allyn notified distributors by letter on 12/15/2008 requesting that they notify their customers. Welch Allyn sent an Urgent: Medical Device Recall letter to distributors and customers on February 26, 2009.
Quantity in Commerce 14,012 devices
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 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 and Original Applicant = MEDICAL RESEARCH LABORATORIES, INC.