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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 09, 2009
Recall Status1 Terminated 3 on March 19, 2012
Recall Number Z-1006-2009
Recall Event ID 50146
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 Software version 2.02 or lower. The ECG analysis/noise issue involves all units manufactured before January 2006 when a design/component change was made.  
Recalling Firm/
Manufacturer		 Welch Allyn Protocol, Inc
8500 Sw Creekside Pl
Beaverton OR 97008
For Additional Information Contact
503-530-7935
Manufacturer Reason
for Recall		 Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
FDA Determined
Cause 2		 Component design/selection
Action Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.
Quantity in Commerce 10, 735
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.
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