Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medtronic AED recall: Medtronic/Physio-Control is recalling certain Lifepak CR Plus automated external defibrillators that, in extremely humid environments, may improperly analyze a patient's heart rhythm and delay or fail to deliver therapy to patients in cardiac arrest. The Medtronic subsidiary began calling customers on Aug. 18 and sending replacement devices on Aug. 19. FDA classified the recall as Class I, the most serious category, on Sept. 16. Several Lifepak CR Plus devices were recalled in Aug. 2008 because of a software glitch (1"The Gray Sheet" Sept. 15, 2008)