GE Datex-Ohmeda Avance CS2 Anesthesia System Recalled for Damaged Flow Sensors
GE Healthcare is recalling 88 Avance CS2 Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could compromise patient safety (damaged tubes), but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 88 units of the GE Datex-Ohmeda Avance CS2 Anesthesia System. The recall is due to a defect where flow sensors could have damaged tubes in the form of small punctures or cuts.
The affected devices are those with installed flow sensors that have an etched manufacturing date of August 2020 (2020-08). The Avance CS2 is intended to provide general inhalation anesthesia and ventilatory support to neonatal, pediatric, and adult patients.
The product was distributed in 36 U.S. states and 26 foreign countries. Healthcare facilities and users should stop using the affected devices and contact GE Healthcare for further instructions.
The recalled product
- Product
- GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 88
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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