FDA Recalls MRL/Welch Allyn AED 20
FDA has issued a Class I recall for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509.
These devices are used by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). The recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
FDA advises healthcare professionals and patients to stop using the recalled product and contact the manufacturer to obtain a loaner AED 20™ at no cost while their unit is being serviced. Welch Allyn says it will pay all costs associated with the upgrade required to correct the issue as well as shipping and handling of the devices. Customers may call the manufacturer at 1-800-462-0777. Welch Allyn said it sent recall letters on Aug. 29, 2007 to its customers who purchased these devices.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/MedWatch/report.htm, by regular mail through a postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm, or by fax at 1-800-FDA-0178.