ZOLL Medical Corp has issued a Class 1 recall for its ZOLL AED Plus Defibrillator, manufactured between May 2004 and February 2009, and distributed from May 2004 through February 9 2009.
Class 1 recalls are the most serious type of recall involving situations in which there is a reasonable probability that use of these products will cause serious injury or death.
According to the FDA, the ZOLL AED is being recalled due to its failure to deliver the defibrillation energy.
The company sent distributors and customers an initial recall letter on February 12, 2009, instructing customers to replace their batteries every three years. The company then sent a follow-up recall letter on March 31, instructing customers to download new software for their devices and to remove any battery replacement reminder labels.
For more information about the recall, visit the company’s Web site. Customers who wish to report adverse reactions or quality problems regarding the device should contact the FDA’s MedWatch Adverse Event Reporting program, either online or via Fax at (800) FDA-0178.