Company: Welch Allyn Protocol, Inc
Date of Enforcement Report 3/11/2009
Class:l

PRODUCT
Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”). Recall # Z-1006-2009

REASON
Reliability issues – potential to shock a non shockable rhythm or not shocking a shockable rhythm;

CODE
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., Beaverton, OR, by letter dated February 26, 2009. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
10,735 units

DISTRIBUTION
Nationwide and Internationallyp>