Z-0914-2026 Class I Ongoing
Recalled by GE Medical Systems China Co., Ltd.
— Wuxi
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- November 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 888 units
Product Description
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
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 Pattern
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.
Code Information
REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.