ZOLL AED Plus Defibrillator 體外自動電擊器 一級回收

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Class 1 Recall: 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 having a heart attack (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.(特定序號設備,因電池問題且自我測試程式,無法偵測電池問題,會造成電擊失效，請參考Zoll所發的顧客提醒信 http://www.fda.gov/medwatch/safety/2009/ZOLL_AEDPlus_CustomerLetter_3-31-09.pdf )
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