GE Medical Systems China Co., Ltd. medical device recall: GE Healthcare Carestation anesthesia system

Reason for recall

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Nov 14, 2025. FDA classified it 34 days later, on Dec 18, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: 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,… GE Medical Systems China Co., Ltd. has 7 recalls in our records.

Recalled products (3)

• Z-0913-2026 Class I Ongoing

  GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

  Codes / lots: REF 1012-9620-222: GTIN 00195278626301; REF 1012-9620-000: GTIN 00840682103985; REF 1012-9620-200: GTIN 00195278439536; REF 1012-9620-202: GTIN 00195278626158; REF 1012-9620-212: GTIN 00195278626561; REF 1012-9650-222: GTIN 00195278626592; REF 1012-9650-000: GTIN 00840682103947; REF 1012-9650-200: GTIN 00195278439529; REF 1012-9650-202: GTIN 00195278626585; REF 1012-9650-212: GTIN 00195278625687; REF 1012-9655-202: GTIN 00195278625953; REF 1012-9620-002: GTIN 00840682124546; REF 1012-9620-012: GTIN 00195278569677; REF 1012-9650-002: GTIN 00840682124560; REF 1012-9650-012: GTIN 00195278569684; REF 1012-9655-000: GTIN 00840682103954; REF 1012-9655-002: GTIN 00840682124539; REF 1012-9655-200: GTIN 00195278439543.

  Quantity: 1277 units

• Z-0914-2026 Class I Ongoing

  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

  Codes / lots: REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.

  Quantity: 888 units

• Z-0915-2026 Class I Ongoing

  GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

  Codes / lots: FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025

  Quantity: 203 units