Three Class 1 Recalls: Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED
Date Recall Initiated: December 15, 2008
Product: Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED
These AEDs were manufactured from October 3, 2002 through January 25, 2007.
Use: This device is used by emergency or medical personnel, or by others who have completed CPR AED training courses. It is intended to treat adults in a heart attack (cardiac arrest). The device analyzes an unconscious patient’s heart rhythm and automatically delivers an electrical shock to the heart if needed to restore a normal heart rhythm.
Welch Allyn Protocol, Inc.
8500 SW Creekside Place
Beaverton, OR 97008
Reason for Recall:
The device may experience:
These issues could lead to a sudden stoppage of the device, may prevent defibrillation of a patient in cardiac arrest, which could lead to death.
Public Contact: Customers who have the recalled devices should contact the company at 1-888-345-5356 between 8 a.m. and 5 p.m. Eastern Standard Time. Customers may also visit the company’s recall website at www.welchallyn.com/AED10Recall for more information or to learn if their unit is subject to this recall.
FDA District: Seattle
FDA Comment: The company sent a recall notification letter to distributors and customers on February 26-27, 2009.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
For More Information please visit FDA MedWatch.