Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation (VCV) Mode 

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.  

Affected Product

Product Names: Carestation 620/650/650c and 750/750c Anesthesia Systems

Full List of Affected Devices

What to Do

• Ensure users are made aware not to use Volume Control Ventilation (VCV) mode on the device until the device has been corrected by GE HealthCare.
• Ensure all potential staff in your facility are made aware of this safety notification and the recommended actions.
• Complete and return the Medical Device Notification Acknowledgement Response Form. 
• Perform the Ventilation Screening Test for each affected Carestation system.
  • If the Carestation system passes the Ventilation Screening Test, you can continue to use the device in accordance with the instructions in the User Reference Manual (URM).

• Use the device in accordance with the instructions in the URM with these changes:
  • Use only Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) mode to mechanically ventilate a patient.
  • Do not use Volume Control Ventilation (VCV) mode to mechanically ventilate a patient.

NOTE: Manual mode of the anesthesia system can be used to provide manual ventilation or allow spontaneous ventilation of the patient.  

Reason for Correction

GE HealthCare is correcting certain Carestation devices 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 through 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 reported no serious injuries or deaths related to this issue.

Device Use

Intended use of the Carestation is to provide monitored anesthesia care, general inhalation anesthesia and/or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics by a clinician qualified in the administration of general anesthesia.

Contact Information

Customers in the U.S. with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.  

Additional FDA Resources (listed in order of most to least recent):

• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.