Class 1 Device Recall AED 10

• Date Initiated by Firm: December 15, 2008
• Date Posted: March 09, 2009
• Recall Status: Terminated 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: 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