FDA-Device2025-12-24Class IPROCESSING DEFECT

GE Healthcare Carestation 750 anesthesia systems recalled for potential unexpected shutdown during power loss

OTHERNationwide distributionMedical devices

What this means

GE Healthcare has recalled certain Carestation 750 anesthesia systems that may unexpectedly shut down if AC power is lost or unplugged. When this happens, the system will not automatically switch to battery backup and will reboot, which can temporarily disrupt ventilation and medication delivery. After rebooting, the system does not return to its previous settings.

If you operate a Carestation 750 A1, 750 A2, 750c A1, or 750c A2 system, contact GE Healthcare immediately
Do not rely solely on this system as your only anesthesia delivery method until you receive guidance from GE
Ensure continuous backup emergency power is in place at your facility
Check GE Healthcare's website or contact your device representative for repair or replacement instructions

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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

888 units

Manufactured in

Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, China

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0914-2026

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