GE Healthcare Carestation anesthesia system, product numb... (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.) – potential unexpected shutdown of care... (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 anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650
Brand
GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.
Lot Codes / Batch Numbers
REF 1012-9620-222: GTIN 00195278626301, REF 1012-9620-000: GTIN 00840682103985, REF 1012-9620-200: GTIN 00195278439536, REF 1012-9620-202: GTIN 00195278626158, REF 1012-9620-212: GTIN 00195278626561, REF 1012-9650-222: GTIN 00195278626592, REF 1012-9650-000: GTIN 00840682103947, REF 1012-9650-200: GTIN 00195278439529, REF 1012-9650-202: GTIN 00195278626585, REF 1012-9650-212: GTIN 00195278625687, REF 1012-9655-202: GTIN 00195278625953, REF 1012-9620-002: GTIN 00840682124546, REF 1012-9620-012: GTIN 00195278569677, REF 1012-9650-002: GTIN 00840682124560, REF 1012-9650-012: GTIN 00195278569684, REF 1012-9655-000: GTIN 00840682103954, REF 1012-9655-002: GTIN 00840682124539, REF 1012-9655-200: GTIN 00195278439543.
Products Sold
REF 1012-9620-222: GTIN 00195278626301; REF 1012-9620-000: GTIN 00840682103985; REF 1012-9620-200: GTIN 00195278439536; REF 1012-9620-202: GTIN 00195278626158; REF 1012-9620-212: GTIN 00195278626561; REF 1012-9650-222: GTIN 00195278626592; REF 1012-9650-000: GTIN 00840682103947; REF 1012-9650-200: GTIN 00195278439529; REF 1012-9650-202: GTIN 00195278626585; REF 1012-9650-212: GTIN 00195278625687; REF 1012-9655-202: GTIN 00195278625953; REF 1012-9620-002: GTIN 00840682124546; REF 1012-9620-012: GTIN 00195278569677; REF 1012-9650-002: GTIN 00840682124560; REF 1012-9650-012: GTIN 00195278569684; REF 1012-9655-000: GTIN 00840682103954; REF 1012-9655-002: GTIN 00840682124539; REF 1012-9655-200: GTIN 00195278439543.
GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No. is recalling GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, R due to Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.
Recommended Action
Per FDA guidance
GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 11/14/2025 via letter using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by Customer/User: "Pending correction by GE HealthCare, you can continue to use the Anesthesia machine with affected power management boards by following the instructions below: 1. Always ensure the device has a secure connection to an AC mains power source. 2. If there is a loss of AC mains power to the system leading to an unexpected system shutdown: - Promptly initiate ventilation using a self-inflating bag connected to an oxygen source. - Assess oxygenation via pulse oximetry. - Because volatile anesthetic agent delivery may transiently be disrupted, supplement with or transition to intravenous anesthetics as needed. - Following system reboot, the system will enter pre-use check. Press "Start Anesthesia or Start Case and then select the "Bypass" button to bypass the checkout. Proceed to selecting the ventilation parameters and volatile agent concentration appropriate for the patient. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to RECALL.FMI34143@gehealthcare.com or submit the acknowledgment using survey." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
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