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GE Healthcare Carestation anesthesia system Power… recallZ-0915-2026 · GE Medical Systems China Co., Ltd. · initiated Nov 14, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems China Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component change control

What the company is doing

GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 11/14/2025 via letter using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by Customer/User: "Pending correction by GE HealthCare, you can continue to use the Anesthesia machine with affected power management boards by following the instructions below: 1. Always ensure the device has a secure connection to an AC mains power source. 2. If there is a loss of AC mains power to the system leading to an unexpected system shutdown: - Promptly initiate ventilation using a self-inflating bag connected to an oxygen source. - Assess oxygenation via pulse oximetry. - Because volatile anesthetic agent delivery may transiently be disrupted, supplement with or transition to intravenous anesthetics as needed. - Following system reboot, the system will enter pre-use check. Press "Start Anesthesia or Start Case and then select the "Bypass" button to bypass the checkout. Proceed to selecting the ventilation parameters and volatile agent concentration appropriate for the patient. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected] or submit the acknowledgment using survey." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recall details

Recall number
Z-0915-2026
Status
Open, Classified
Initiated by the company
Nov 14, 2025
Posted by the FDA
Dec 18, 2025
Recalling firm
GE Medical Systems China Co., Ltd.
Quantity
203 units
Product code
BSZ
FDA submissions
K151570, K213867
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Moldova, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Vietnam.

Product description

GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

5 devices cleared under K151570, K213867 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98064).

Sources and updates

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