GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 650c A1

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation 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.

GE Healthcare issued an URGENT MEDICAL DEVICE notice to its consignees on 03/21/2025 distributed via traceable means. The notice explained the safety issue with the device, potential risk, and requested the following actions be taken: The anesthesia system may continue to be used following the instructions below: Perform the Ventilation Screening Test (specified in Appendix 1) 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 the instructions below: 1. Use the device in accordance with the instructions in the User Reference Manual (URM) with these changes: i. Use only Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) mode to mechanically ventilate a patient. ii. 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. 2. 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. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions, and retain this document for your record. GE HealthCare will correct all devices that fail the Ventilation Screening Test at no cost. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. Notice sent on 04/21/25 with updated ventilation screening test instructions.

• FDA enforcement recordOfficial FDA database entry for Z-1634-2025
• FDA 510(k) clearance · K151570The device's official FDA premarket clearance record
• FDA device classification · BSZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5160The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE Medical Systems China Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.