Safety Alert Number 0904251


ZOLL Medical Corporation, ZOLL AED Plus Defibrillator

Date Recall
Initiated:
February 12, 2009
Product: ZOLL AED Plus Defibrillator
This product was manufactured from May, 2004 through February, 2009 and distributed from May, 2004
through February 9, 2009. Use: This device is used by emergency or medical personnel, by others who have completed CPR AED training
courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an
unconscious patient's heart rhythm and instructs the user to press a button that delivers an electrical
shock to the heart to restore a normal heart rhythm. Recalling Firm: ZOLL Medical Corporation
269 Mill Road
Chelmsford, Massachusetts 01824
Reason for Recall: The AED failed to deliver the defibrillation energy. Public Contact: The company may be contacted at 1-978-421-9655. FDA District: New England
FDA Comments: The company sent their distributors and customers an initial recall letter on February 12, 2009 by certified
mail. This letter instructed customers to replace their batteries every three years. The company then sent
their distributors and customers a follow-up recall letter on March 31, 2009 by certified mail. This letter
instructed customers to download new software for their devices and to remove any battery replacement
reminder labels. ZOLL will send an email notice to all customers who included their email address as part of their contact
information. ZOLL will also publish information about the recall in industry magazines. For more information about this recall, please see the company's website at:
http://www.ZOLLAEDPlusbatteryhelp.com
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable
probability that use of these products will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced
with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by
regular mail or by FAX. • Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178