Event Medical LTD - Inspiration Ventilator System - Class 1 Recall

Inspiration Ventilator System, i Series and LS 12.1 LCD The Inspiration 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O. The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support. The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts