Respironics Esprit ventilator
This article was originally published in The Gray Sheet
Executive Summary
FDA issues Class I recall notice for computer-controlled ventilator July 2, following an agreement last month to reclassify what Respironics had deemed a "field action." The recall - initiated in June 2001 after a material used in the ventilator was found to predispose the device to early failure - included 419 U.S. and 330 international units. The material has been changed, and the recall is 100% complete, according to the firm...