GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | November 14, 2025 |
| Reported | December 24, 2025 |
| Recalling firm | GE Medical Systems China Co., Ltd. |
| Country / region | China 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. |
Hazard
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.
Affected products
- GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
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