The U.S. Food and Drug Administration (FDA) has issued an early alert regarding a potentially high-risk issue in certain anesthesia systems manufactured by GE HealthCare. Clinical, quality, and regulatory teams in healthcare facilities should take immediate notice of this alert to mitigate the potential risks associated with these systems. This announcement concerns issues that could lead to unexpected system shutdowns, adversely affecting patient safety during anesthesia delivery.
What anesthesia systems are affected?
The systems affected include GE HealthCare’s Carestation 600 and 700 Series Anesthesia Systems. Specifically, these systems are vulnerable if they contain certain power management boards installed either during initial manufacturing or as spare parts. Carestation devices are typically used to provide inhalation anesthesia and ventilatory support to patients of various age groups, including neonatal, pediatric, and adult patients.
GE HealthCare has identified that under specific circumstances—such as a loss of connection to an AC mains power source or mains power failure—these systems may not automatically transition to battery power mode. Instead, the devices would shut down unexpectedly, rebooting only when power is restored. This malfunction interrupts mechanical and manual ventilation, as well as volatile agent delivery. Additionally, post-reboot, the systems do not revert to previously set ventilation parameters, requiring user adjustments.
What are the risks to patients?
This issue carries significant risks. If the anesthesia system is disconnected from AC power and does not switch seamlessly to battery power, key functions such as ventilation and anesthetic agent delivery may be disrupted. If healthcare professionals fail to address this situation promptly, it could lead to a critical interruption in breathing support for patients, posing a life-threatening condition.
Fortunately, as of November 26, 2025, GE HealthCare has not reported any cases of serious injuries or fatalities directly associated with this issue. Nevertheless, healthcare providers must remain vigilant and follow recommended precautions to minimize risks.
What should users do?
GE HealthCare has communicated with affected customers to provide recommendations aimed at mitigating the risk of system shutdowns. Users should adhere to the following guidance:
- Ensure the device is securely connected to an AC mains power source at all times.
- In the event of an unexpected system shutdown, promptly connect a self-inflating bag coupled with an oxygen source to the patient’s airway (e.g., an endotracheal tube) and manually initiate ventilation.
- Monitor oxygenation levels continuously through pulse oximetry to ensure adequate oxygen delivery.
- Since volatile anesthetic agent delivery may be temporarily impacted, consider supplementing or transitioning to intravenous anesthetics as required.
- Following a system reboot, the device will enter its pre-use check. Use the “Bypass” function to expedite setup and reset ventilation parameters and anesthetic concentrations.
- Inform all staff and potential users within your facility about this safety notification and ensure they understand the recommended response procedures.
For more detailed device identification, users can access the unique device identifier (UDI) located on product labeling. Healthcare professionals may utilize the AccessGUDID database as a resource for device-specific identification.
How can adverse events be reported?
Healthcare professionals and consumers in the U.S. are encouraged to report quality issues or adverse reactions linked to affected devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Alternatively, customers can contact GE HealthCare directly at 1-800-437-1171 with any questions or concerns about this recall or to report an incident.
What are the next steps?
The FDA is monitoring this situation closely. No injuries have been reported to date, but the issue remains under active review due to its serious implications. Updates will be posted as new information becomes available. In the meantime, following the FDA’s and GE HealthCare’s recommended protocols is essential for maintaining patient safety and preventing adverse outcomes.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Healthcare providers are encouraged to consult the official FDA announcement and manufacturer updates for the most current and accurate guidance.