Practical implication
Healthcare facilities must complete preoperative checks, manage emergency O2 flow during usage, and return the response form to GE Healthcare within a maximum of 30 days.
The ANSM (France) issued a safety notice concerning GE Healthcare anesthesia ventilators Aisys CS2, Aisys CS2 with FetCible, and S/5 Aisys due to an issue that may cause the systems to automatically switch to an emergency O2 mode, which interrupts halogen agent delivery and could affect patient safety. Although no injuries have been reported, this requires immediate attention and corrective actions by healthcare facilities.
What changed: Healthcare facilities are required to perform preoperative checks and adjust emergency O2 flow based on patient needs when this mode is activated. GE Healthcare is to inspect and correct affected products at no charge, with healthcare facilities required to respond to the notification within 30 days.
Why it matters: This safety issue poses a risk to patient safety by potentially reducing the anesthetic effect during surgeries. It is crucial for healthcare facilities to follow the recommended actions to ensure patient safety and regulatory compliance.
Practical implication: Healthcare facilities must complete preoperative checks, manage emergency O2 flow during usage, and return the response form to GE Healthcare within a maximum of 30 days.
View original source
- Source: ANSM (France) - Safety information feed
- Published at source: 2026-08-31T00:00:00.000Z
- Discovered by monitor: 2026-08-31T21:32:57.875Z
Published from the regulator source ingestion pipeline after PV impact triage.
