Welch Allyn Recalls 580 AED20 Defibrillators
MRL, Inc., a company acquired by Welch Allyn in 2003, today announced a voluntary worldwide Class I recall of 580 AED20 Automatic External Defibrillators manufactured between April and October of 2003, with serial numbers 205199 through 205786. These devices 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. 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. Customers with questions may contact the company at 1.800.462.0777 or 1.847.520.0300 for more information.
June 15, 2006 Related topics: Product Recalls, Cardiology