FDA classifies Physio Control’s AED correction as a Class I action
The U.S. Food and Drug Administration has classified Physio-Control, Inc.’s medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) as a Class I action. Some of these devices manufactured between May 2004 and April 2007 are configured incorrectly. The shock button can not be located as it is covered in the fully automated device. This may lead to a delay in delivery of therapy as a patient complained. Physio-Control has notified replacement devices at no charge to all the affected customers.
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