FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators manufactured between 3/29/07 and 8/9/07 – Class 1 Recall
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.
There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient's ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the defective part that stores an electrical charge on the circuit board. The company plans to replace all affected units and has set up a call center for customers.
Read the complete MedWatch 2007 Safety Summary including a link to the Class 1 Recall Notice, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#aed10
