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Cardiac Science issues recall for some AEDs
Devices may be susceptible to failure under certain conditions.
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Cardiac Science Corporation has issued a voluntary device recall for approximately 12,200 of its automatic external defibrillators.
The defibrillators may not be able to deliver adequate therapy during a resuscitation attempt under certain conditions, potentially leading to serious adverse events or death, according to an FDA statement.
The recall applies to devices manufactured or serviced between Oct. 19, 2009 and Jan. 15, 2010, and is separate from the company’s Nov. 13 announcement of a voluntary medical device correction. Defibrillator models included in the recall are the Powerheart 9300A, 9300E, 9300P, 9390A and 9390E; the CardioVive 92532; and the CardioLife 9200G and 9231. The company has offered to replace the recalled models at no charge, and anticipated replacement shipments are scheduled to begin on Feb. 15.
Clinicians can confirm whether or not their device is included in the recall here.
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