Critical Updates: GE Healthcare Carestation Recall

GE HealthCare Carestation anesthesia systems are subject to an FDA Class I recall for a power‑management defect that can cause unexpected system reboots with transient loss of ventilation and volatile‑agent delivery during cases.

This affects operating‑room safety and increases the likelihood of unplanned shutdowns that require prompt manual ventilation and clear workflow contingencies.

Power‑management faults create an acute intraoperative patient‑safety risk by interrupting mechanical ventilation, volatile delivery, and alarm continuity. This recall challenges assumptions about automatic battery switchover and continuous uptime: a defective power‑management board can produce a synchronous reboot rather than a seamless battery transition, creating gaps in ventilation and anesthetic delivery that demand rapid manual intervention and coordinated systems‑level mitigation. A rapid local operational review of Carestation deployment, UPS configuration, and backup‑device availability is required.

Affected models include Carestation 750 A1, Carestation 750 A2, Carestation 750c A1, and Carestation 750c A2. Clinicians and biomedical engineering teams should follow the manufacturer’s recall instructions, complete the acknowledgement and tracking steps in the notice, and record affected units under the Carestation 750 product listing for facility traceability. Check inventory immediately against the listed REF, GTIN, and serial/model identifiers and tag units for remedial action or service follow‑up.

In sudden power loss, enact these immediate operational steps: (1) Assume manual ventilation and secure the airway with a self‑inflating bag connected to a reliable oxygen source to restore ventilation without delay. (2) Transition anesthetic delivery to alternate gas sources or an available backup anesthesia machine; if volatile delivery is interrupted, supplement with intravenous anesthetics. (3) Confirm AC mains connection, UPS/backup supply status, and the machine battery state while a second clinician manages ventilation. (4) Maintain continuous monitoring (pulse oximetry, capnography, blood pressure, and ECG or arterial line as appropriate) to preserve oxygenation and hemodynamics. (5) Escalate to on‑call biomedical engineering and activate local device‑retrieval, tagging, and service pathways. Run a brief simulation or team briefing to rehearse these steps with OR staff and biomed teams to ensure coordinated responses.

Report device failures through institutional incident‑reporting systems and notify GE HealthCare Service for recall queries (GE HealthCare Service: 800‑437‑1171) as neutral operational guidance, while routing internal alerts to biomedical engineering, OR leadership, and risk/safety teams for immediate action. Complete internal reporting and, where applicable, submit external medical‑device reports or adverse‑event notifications to your regulatory office per institutional policy. Document each event in the device log, retain recall acknowledgement records, and update the facility recall‑tracking register for compliance and audit readiness.

Key Takeaways:

• What’s new? FDA Class I recall of Carestation 750‑series cites a power‑management defect that can prompt unexpected shutdowns, interrupt ventilation and anesthetic delivery, and require immediate mitigation.
• Who’s affected? Anesthesia teams and operating rooms using Carestation 750‑series devices — prioritize unit identification, backup ventilation readiness, and staff briefing.
• What changes next? Immediately check inventory against REF/GTIN/serial identifiers, enact mitigation steps (manual ventilation, backup devices, UPS verification), and complete local and manufacturer reporting and documentation.