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: Heart Device Recall Blog : July 2006 : Article

FDA MedWatch - Welch Allyn PIC 50 Automated External Defibrillators

Date: Fri, 7 Jul 2006 15:44:40 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA MedWatch - Welch Allyn PIC 50 Automated External Defibrillators

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Welch Allyn PIC 50 Automated External Defibrillators
Audience: Emergency services personnel and risk managers

MRL, Inc., and FDA notified healthcare professionals of a Class I recall of Welch Allyn PIC 50 Automated External Defibrillators, catalog #97108X manufactured from March 2002 through October 2004. An electrical contact problem may result in the device's failure to provide a defibrillation shock, that could result in delay or failure to resuscitate the patient. This failure may be accompanied by various error messages on the display panel, including the "Defib Comm" error message.

Read the complete MedWatch Safety summary, including links to the FDA Recall Notice and previous MedWatch alert at:


 
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