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/ Manufacturer |
Welch Allyn Protocol, Inc 8500 Sw Creekside Pl Beaverton OR 97008
|
For Additional Information Contact |
503-530-7935
|
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
|
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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.
|