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Friday, April 17, 2009

FDA Recall: ZOLL Medical Corporation AED Plus Defibrillator

If you have AEDs (Automated External Defibrillators) in your facility(ies), then you should check to see if you have the ZOLL AED Plus Defibrillator manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009. These models have been recalled by the FDA because the AED failed to deliver the defibrillation energy.

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.

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.

Contact Information

For more information about this recall, please see the company’s website at: http://www.zollaedplusbatteryhelp.com/

ZOLL Medical Corporation 269 Mill RoadChelmsford, Massachusetts 01824, (978) 421-9655

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