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

The Food and Drug Administration (FDA) released the following information:

Contact:
MRL Inc.
1-800-462.0777 or 1-847-520-0300

MRL, Inc., a Welch Allyn Company, announced it is initiating a voluntary worldwide Class I recall of 580 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between April and October of 2003, with serial numbers 205199 through 205786. These 580 AED20's may experience failure or unacceptable delay in analyzing the patient's ECG and may fail to deliver appropriate therapy, which possibly could result in failure to resuscitate the patient. This will occur in combination with an error message on the device display reading "DEFIB COMM FAIL SELF TEST FAILED." This problem occurs because of an intermittent electrical connection within the device.

The company has received 30 related complaints about devices in this group of AED20's, corresponding to 5 percent of the 580 recalled devices which the company deems an unacceptable risk. In one instance the "Defib Comm" error delayed patient resuscitation. The company has taken corrective action and no other devices besides those manufactured between the above dates are subject to this recall.

MRL, Inc initiated notification via certified mail on June 14, 2006 to its customers who purchased AED20's in this group of devices 369 of which were sold within the US and 211 outside of the US. Owners of this defibrillator should contact MRL, Inc. to obtain a loaner AED20 at no cost while their unit is being serviced. MRL, Inc. will pay all costs associated with shipping, handling and replacement of the units "DEFIB" board.

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 I recall. The FDA defines Class I 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 or 1.847.520.0300 for more information. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.


Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.