Class 1 Device Recall AED 10

• Date Initiated by Firm: December 15, 2008
• Date Posted: March 10, 2009
• Recall Status: Terminated 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: 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