Cardiac Science Recalls Over 12,000 AEDs

Reed Miller

February 10, 2010

February 10, 2010 (Bothell, Washington) — Cardiac Science is recalling and replacing about 12,200 automated external defibrillators (AEDs) due to a manufacturing problem that may prevent them from delivering therapy [1].

The FDA announced February 9 that Cardiac Science is advising customers to take the following AED models out of service: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532; and CardioLife 9200G and 9231 [2]. Customers who have received one of these models since October 19, 2009 should contact the company for a replacement. Replacements will begin shipping on February 15.

The company says this latest recall is unrelated to the company's November 13, 2009 "medical device correction" to 10 AED models, reported by heartwire .

Cardiac Science says it has not received any adverse-event reports or complaints about the devices. The problem was detected through the company's own quality systems.


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