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AED recalls

This article was originally published in The Gray Sheet

Executive Summary

Cardiac Science, Inc. initiates 5,530-unit recall of Powerheart 9200RD and 9210RD automatic external defibrillators during the week of May 24, the Irvine, Calif. company discloses June 1 in an 18-K filing with the SEC. So far, 650 AEDs containing faulty capacitors have been identified in the field through the devices' RescueReady indicator. Cardiac Science's decision to recall the remaining AEDs resulted from a corrective and preventive action (CAPA) analysis following a March 29 FDA warning letter. The firm notes that itsG3 line, 510(k)-cleared in July 2003, is unaffected. G3 accounts for 95% of Cardiac Science's AED sales. Cardiac Science also reports that a 4,730-battery recall and replacement begun May 4 "has been substantially completed." The G3 battery error originated with the firm's supplier, according to Cardiac Science, which estimates total costs from both recalls at $1 mil.-$1.5 mil., with potential battery reimbursement coming from suppliers. In April, Medtronic recalled LifePak AEDs for battery malfunctions and announced a Class I ICD recall due to a faulty capacitor...
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