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GE HealthCare is correcting certain Carestations due to the risk that they may not provide effective ventilation when used in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation. If this issue occurs, it will be apparent to the user via observation and multiple alarms. 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. Additional alarms including Apnea, EtCO2 low, MVexp low, RR low, and TVexp low will also alert the user to inadequate ventilation.
The use of affected product may cause serious adverse health consequences, including failure of ventilation resulting in hypoxia (inadequate oxygen levels) and death.
At this time, GE HealthCare has not reported any serious injuries or deaths related to this issue.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
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