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FDA-Device2025-12-24Class IPROCESSING DEFECT

GE Healthcare Carestation 600/700 anesthesia system recalled for potential unexpected shutdown during power loss

GE
ELECTRICAL SHOCKOTHERNationwide distribution

Contact GE Healthcare about Carestation anesthesia system recall

GE Healthcare has recalled certain Power Management Boards in Carestation 600 and 700 Series anesthesia systems. If AC power is lost or unplugged, these systems may unexpectedly shut down instead of switching to battery backup, causing temporary disruption of ventilation and medication delivery. After restart, the system will not return to its previous settings.

  • If you operate a Carestation 600 or 700 Series system, contact GE Healthcare immediately to determine if your unit contains the affected power management board (FRU 2076139-001-S)
  • Do not rely solely on this system as your only anesthesia delivery device until you confirm the status of your equipment
  • Ensure continuous backup emergency power is in place for your facility
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.

Sold states
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.
Affected count
203 units
Manufactured in
Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, China
Products
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0915-2026

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