The Recall Desk
CriticalFDA (Devices)·Z-0913-2026·Announced 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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

GE Healthcare Carestation anesthesia systems are being recalled, covering the Carestation 610 A1, 620 A1, 620 SE A1, 630 A1, 650 A1, 650 SE A1 and 650c A1 under the REF numbers listed in the enforcement record.

There is a potential for 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 the 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 battery supply mode and will reboot. GE states that a temporary disruption of mechanical ventilation, manual ventilation and volatile agent delivery may occur, and that following the reboot the system will not return to the previous ventilation settings.

The record lists 1,277 units. Distribution was worldwide, including nationwide in the United States and to a wide range of other countries. The FDA has classified the action as Class I, its most serious category.

Facilities should follow GE's instructions immediately.

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 — Anesthesia system
Hazard
  • unexpected-shutdown
  • power-failure
  • ventilation-disruption
  • class-i

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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