Agency classClass IOur severity:Critical FDA (Devices)·Z-0915-2026·Announced 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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

The GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit, part 2076139-001-S, is being recalled.

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 203 units, distributed between June 2, 2025 and October 21, 2025. 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 Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Manufacturer: GE Medical Systems China Co., Ltd.
Category: Medical Device — Anesthesia system
Hazard: unexpected-shutdown
power-failure
ventilation-disruption
class-i
Affected units: 203

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)

FRU 2076139-001-S
distributed between June 2
2025 and October 21
2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems China Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · GE Medical Systems China Co., Ltd.

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Same hazard · unexpected shutdown