Cardiac Science Corp. (NSDQ:CSCX) will replace 24,000 automated external defibrillators implicated in a November 2009 recall.
The Bothell, Wash.-based company’s Powerheart, CardioVive, Nihon Kohden and GE Responder AEDs have electrical component flaws that may cause device failures. The flaws could not be remedied through software patches, according to the Food & Drug Administration.
The company will replace the AEDs used by police and fire departments and ambulance crews first, followed by hospitals and medical clinics. The FDA recommends that other owners of the devices continue their use until a replacement arrives, because the chances for device failure are remote.
In April 2010, the FDA warned that 280,000 external defibrillators deployed around the world could malfunction due to faulty components made by Cardiac Science.
Cardiac Science issued a recall for its Powerheart and CardioVive models in November 2009, according to an April 27 press release. Since then, the federal watchdog said it’s learned that Cardiac Science defibrillators marketed by Nihon Kohden and GE Healthcare have similar problems, according to the release.
Cardiac Science issued a software upgrade for the devices’ self tests in February 2010 (for the Powerheart defibrillators) and in June (for the other affected devices), the FDA said. The watchdog agency’s review of the updated software, however, indicated that the software detects some, but not all, electrical component defects.
Cardiac Science estimates the new recall will add between $10 and $15 million to the $18.5 million expense from the November 2009 recall and expects to take a charge to earnings in the second quarter this year. The company plans borrow from a $15 million credit line, in combination with existing cash resources, to finance the recall.