CareStation 650C A1 (GE Healthcare) – ventilation ineffective (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
Brand
GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.
Lot Codes / Batch Numbers
GTIN 00840682103954, Serial Numbers: SM823080001MA, SM823080002MA, SM823080003MA, SM823080004MA, SM824210002WA, SM824210003WA, SM824210004WA, SM824230005WA, SM824230006WA, SM823440005WA, SM823440006WA, SM823440007WA, SM823440008WA, SM823050001WA, SM823050002WA, SM823050003WA, SM823050004WA, SM823050005WA, SM823060001WA, SM823060002WA, SM824030001MA, SM824030002MA, SM824030003MA, SM824030004MA, SM824030005MA, SM824030006MA, SM824030007MA, SM824030008MA, SM824030009MA, SM824030010MA, SM823120001MA, SM824320007WA, SM823010001WA, SM823430004WA, SM824050003MA, SM824050004MA, SM824050005MA, SM824050006MA, SM824050007MA, SM824050001WA, SM824050002WA, SM823230001MA, SM823230002MA, SM824040001WA, SM824450010WA, SM823410001WA, SM823410002WA, SM823420003WA, SM823480001WA, SM823170001MA, SM823170002MA, SM823170003MA, SM823170004MA, SM823170005MA, SM823170006MA, SM823280001MA, SM823280002MA, SM823280003MA, SM824430009WA, SM823370001MA, SM823370002MA, SM824410006MA, SM824410007MA, SM824410008MA, SM824440009MA, SM824440010MA, SM824440011MA, SM824440012MA, SM824440013MA.
Products Sold
GTIN 00840682103954, Serial Numbers: SM823080001MA, SM823080002MA, SM823080003MA, SM823080004MA, SM824210002WA, SM824210003WA, SM824210004WA, SM824230005WA, SM824230006WA, SM823440005WA, SM823440006WA, SM823440007WA, SM823440008WA, SM823050001WA, SM823050002WA, SM823050003WA, SM823050004WA, SM823050005WA, SM823060001WA, SM823060002WA, SM824030001MA, SM824030002MA, SM824030003MA, SM824030004MA, SM824030005MA, SM824030006MA, SM824030007MA, SM824030008MA, SM824030009MA, SM824030010MA, SM823120001MA, SM824320007WA, SM823010001WA, SM823430004WA, SM824050003MA, SM824050004MA, SM824050005MA, SM824050006MA, SM824050007MA, SM824050001WA, SM824050002WA, SM823230001MA, SM823230002MA, SM824040001WA, SM824450010WA, SM823410001WA, SM823410002WA, SM823420003WA, SM823480001WA, SM823170001MA, SM823170002MA, SM823170003MA, SM823170004MA, SM823170005MA, SM823170006MA, SM823280001MA, SM823280002MA, SM823280003MA, SM824430009WA, SM823370001MA, SM823370002MA, SM824410006MA, SM824410007MA, SM824410008MA, SM824440009MA, SM824440010MA, SM824440011MA, SM824440012MA, SM824440013MA.
GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No. is recalling GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 due to GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE HealthCare has become aware that 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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026