FDAnews
www.fdanews.com/articles/100668-welch-allyn-issues-third-aed-recall-in-18-months

Welch Allyn Issues Third AED Recall in 18 Months

November 5, 2007

The FDA announced a Class I recall of Welch Allyn automatic external defibrillators (AEDs) 10 — the third recall of Welch Allyn AEDs in the past 18 months.

Devices manufactured between March 29 and August 9 may experience failure or unacceptable delay in analyzing a patient’s electrocardiogram, resulting in possible failure to deliver the appropriate therapy, the FDA said.

In July 2006, a Welch Allyn company issued a Class I recall of 1,184 PIC50 AEDs manufactured between February 2002 and October 2004.

That action came on the heels of a Class I recall posted by the FDA June 15 for Welch Allyn AED 20 manufactured from April through October 2003.