GE Healthcare Carestation anesthesia system, product number… recallZ-0913-2026 · GE Medical Systems China Co., Ltd. · initiated Nov 14, 2025

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-0913-2026

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

1277 units

Product code

BSZ

FDA submissions

K151570

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, 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 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• Carestation 650 A1

  Datex-Ohmeda Inc · Gas-machine, anesthesia
  2 recalls3,109 reports
• Carestation 620 A1

  Datex-Ohmeda Inc · Gas-machine, anesthesia
  2 recalls2,015 reports
• Carestation 650c A1

  Datex-Ohmeda Inc · Gas-machine, anesthesia
  2 recalls70 reports

Other products in the same recall event

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

• Z-0914-2026 · Open, Classified
  GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, …
• Z-0915-2026 · Open, Classified
  GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S