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Serious riskFDA DeviceClass I

GE Healthcare Carestation anesthesia recalled for potential shutdown

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.

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

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
888 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-0914-2026

In the FDA's words

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 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. REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463. 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: 888 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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