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Serious riskFDA DeviceClass I

GE Healthcare Carestation power boards recalled for shutdown risk

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.

From the FDA notice · Read the official notice ↗ · All GE recalls

What to do

  1. 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)
  2. Do not rely solely on this system as your only anesthesia delivery device until you confirm the status of your equipment
  3. Ensure continuous backup emergency power is in place for your facility
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
203 units
Illnesses reported
None reported
Manufactured in
Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, China
Classification
Class I
Recall number
Z-0915-2026

In the FDA's words

Description
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S 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. FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025 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. Affected quantity: 203 units
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.

3 products in this recall

GE Healthcare Carestation anesthesia systems recalled for shutdown risk

GE Healthcare is recalling certain Carestation 600 and 700 Series anesthesia systems, along with a related power management board part, because they may unexpectedly shut down if AC power is unplugged or lost. These systems have no continuous backup power and do not automatically switch to battery, so they reboot and may briefly interrupt ventilation and anesthetic delivery without returning to previous settings. The recall covers 3 product entries with about 2,368 units affected, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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