GE Healthcare is recalling CARESCAPE R860 Ventilator due to early failure of the backup batteries, including replacement backup batteries, manufactured on or after April 1, 2019, because the batteries may run out before they are expected to do so. If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
