Z-0915-2026Class I

GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU)...

Name: Z-0915-2026 GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU)...
Creator: GE Medical Systems China Co., Ltd.
Published: 2025-11-14
License: https://open.fda.gov/license/

GE Medical Systems China Co., Ltd. / initiated 2025-11-14 / Open, Classified

FDA source

GE Medical Systems China Co., Ltd. began a recall of GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S on 2025-11-14. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0915-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-14
Posted: 2025-12-18
Recalling firm: GE Medical Systems China Co., Ltd.
Product: GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: 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: Component change control
Action: 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.
Quantity in commerce: 203 units
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 codes and lots: FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0915-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0913-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0914-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0915-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code BSZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)