GE Recalls Carestation Anesthesia Devices

GE HealthCare is recalling (Class 1 device correction) certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode. “If this issue occurs, it will be apparent to the user through observation and multiple alarms,” a recall notice says. “The inflated bellows, visible through transparent glass, will stop moving and an audible alarm and visual Unable to Drive Bellows message will alert the user.” Using an affected device may cause serious adverse health consequences, including failure of ventilation resulting in hypoxia (inadequate oxygen levels) and death.  

The device is intended to provide monitored anesthesia care, general inhalation anesthesia and/or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). To date, GE HealthCare has not reported any serious injuries or deaths related to the issue.