Regulatory News In Brief
Cardiac Science AEDs: Cardiac Science initiated a field correction Nov. 13 on several models of its Powerheart and CardioVive automated external defibrillator devices that may not delivery therapy during a resuscitation attempt. AED display screens and audible indicators may not accurately indicate whether the device is functioning properly, FDA notes in a Nov. 19 safety communication. About 300,000 devices are potentially affected, and a software correction will not be available until May 2010. Cardiac Science recommends customers leave their AEDs in service, but FDA urges users to seek alternative products, if possible. The company stopped production on some Powerheart AEDs in late June after discovering a resistor malfunction, but resumed shipments Aug. 10. AEDs produced since August are unaffected, the firm stresses. The company earlier predicted that the quality issues could cost upwards of $20 million to resolve (1"The Gray Sheet" Aug. 17, 2009)
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
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