Source: US Department of Health and Human Services – 3
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
Product
Ref Number
UDI Number
Carestation 620 A1
1012-9620-200
00195278439536
Carestation 650C A1
1012-9655-200
00195278439543
Carestation 650 A1
1012-9650-200
00195278439529
Carestation 620 A1
1012-9620-000
00840682103985
Carestation 650 A1
1012-9650-000
00840682103947
Carestation 650c A1
1012-9655-000
00840682103954
Carestation 620 A2
1012-9620-002
00840682124546
Carestation 650 A2
1012-9650-002
00840682124560
Carestation 650c A2
1012-9655-002
00840682124539
Carestation 650 SE A2
1012-9650-012
00195278569684
Carestation 620 SE A2
1012-9620-012
00195278569677
Carestation 750 A1
1012-9750-000
00840682145596
Carestation 750c A1
1012-9755-000
00840682146425
Carestation 750 A2
1012-9750-002
00840682146470
Carestation 750c A2
1012-9755-002
00840682146463
What to Do
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.
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):
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 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.
Content current as of:
06/23/2025
Regulated Product(s)