The Recall Desk

FDA (Devices) recall action 98064

GE Medical Systems China Co., Ltd. recalled 3 products on 2025-12-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-12-24
Critical
3
Units
2,368

Why these products were recalled

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 …

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 occ…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • CriticalFDA (Devices)··2025-12-24

    Carestation 750 anesthesia systems recalled over potential unexpected shutdown

    GE Medical Systems is recalling 888 Carestation 750 series anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The action is Class I.

    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: Carestatio
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2025-12-24

    Anesthesia power management boards recalled over potential unexpected system shutdown

    GE Medical Systems is recalling 203 Carestation anesthesia system Power Management Board field replaceable units over potential unexpected shutdown if AC mains power is lost.

    Product
    GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2025-12-24

    Anesthesia systems recalled over potential unexpected shutdown on mains power loss

    GE Medical Systems is recalling 1,277 Carestation anesthesia systems over potential unexpected shutdown if AC mains power is unplugged or fails. The FDA has classified the action as Class I.

    Product
    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
    Category
    Distribution
    0 states