GE HealthCare Issues Correction for Carestation Devices

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, according to an FDA alert.

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. 

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, the FDA says.

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, the FDA says.

Affected Product

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

FDA Recommendations:

On March 21, 2025, GE HealthCare sent all affected customers an urgent medical device correction notice recommending the following actions:  

• 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). 

If the Carestation system fails the Ventilation Screening Test and must be used prior to the system being corrected by GE HealthCare, follow these instructions:

• 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.  

See the FDA website for the full list of affected devices.