The Recall Desk
HighFDA (Devices)·Z-0914-2026·Announced 2025-12-24

[pending] GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1,

Pending LLM rewrite. Source: FDA_DEVICE Z-0914-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

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: Carestatio
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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

Distributed nationwide across the United States.

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