Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Another heart defibrillator has fallen under a Class I recall by the Food and Drug Administration (FDA). The recall on ZOLL AED Plus Defibrillators was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest.

The recalled devices were manufactured from May 2004 through February 2009 and distributed from May 2004 through February 9, 2009. The defibrillators that fall under the recall have serial numbers in which the last six numbers are under 200000. Defibrillators obtained prior to February 14, 2009 should have serial numbers under 200000 and fall under the recall.

The recall follows a series of letters sent in February and March 2009 to distributors and customers with recommendations and instructions for customers on specific steps to mitigate the identified problems with the device. The February letter instructed customers to replace their batteries every three years. The March follow-up letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels. The new software will detect and prevent potential battery problems that could develop with 123A Lithium batteries in the future.

Software upgrades can be found at www.zollaedplusbatteryhelp.com.

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.

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.

Source: FDA

This entry was posted on Friday, April 10th, 2009 at 7:00 am and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.