Anesthesia power management boards recalled over potential unexpected system shutdown

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

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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