The Recall Desk
HighFDA (Devices)·Z-0913-2026·Announced 2025-12-24

[pending] GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1,

Pending LLM rewrite. Source: FDA_DEVICE Z-0913-2026.

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 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
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 (18)

  • 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.

Distribution

Distributed nationwide across the United States.

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