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 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
This recall is currently active, issued December 18, 2025. It was issued by Ge Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No..
- Recall Initiated
- November 14, 2025
- Posted
- December 18, 2025
- Recall Number
- Z-0913-2026
- Quantity
- 1277 units
- Firm Location
- Xin Wuxi China
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
Lot / Code Info
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.
Root Cause
Component change control
Action Taken
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.