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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

MRL, Inc. a Welch Allyn Company Issues a Voluntary Worldwide Recall of Selected AED20 Automatic External Defibrillators

Contact:
Tom McCall
1-315-685-3696 / 1-315-857-7248

FOR IMMEDIATE RELEASE -- Buffalo Grove, IL -- May 10, 2005 -- MRL, Inc., a Welch Allyn Company, today announced it is initiating a voluntary worldwide recall of 597 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between February and July of 2004. The AED20 may display a “Defib Comm” error message on the device display during use resulting in a failure of the device to analyze the patient’s ECG and deliver the appropriate therapy which prevents the defibrillator from resuscitating a patient. This problem occurs when an impact to the exterior of the AED20 causes a circuit board connector to perforate an insulation shield enabling an electrical short between the connector and the external housing of the AED20.

The company has received 12 related complaints with this specific group of AED20’s, including one instance in which the short may have prevented patient resuscitation. This corresponds to 2 percent of the 597 recalled devices. The company has taken corrective action and no other devices besides those manufactured between the above dates are subject to this voluntary recall.

MRL, Inc initiated notification via certified mail on May 5, 2005 to its customers who purchased AED20’s in this group of devices (296 of which were sold within the US and 301 outside of the US). The company is providing customers with a loaner AED20 at no cost while their unit is being serviced and will pay all costs associated with shipping, handling and corrective service.

This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration (FDA). FDA has determined that this action is a Class 1 recall. The FDA defines Class 1 as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Customers with questions may contact the company at 1-800-462-0777 for more information.

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