GE Datex-Ohmeda Aisys CS2 Anesthesia System Recalled for Damaged Flow Sensors
GE Healthcare is recalling 101 Aisys CS2 Anesthesia Systems because flow sensors may have damaged tubes, posing a risk to patients.
What this means for you
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 intended for life-support functions (anesthesia and ventilation) where a defect (damaged tubes) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling 101 units of the GE Datex-Ohmeda Aisys 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 identified by installed flow sensors with an etched manufacturing date of August 2020 (2020-08).
The Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients, including neonatal, pediatric, and adult patients. The device is designed for volume or pressure control ventilation.
The product was distributed in 34 U.S. states and 26 foreign countries. Healthcare facilities and users should stop using the affected devices and contact GE Healthcare for further instructions on the recall.
The recalled product
- Product
- GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is 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
- Affected units
- 101
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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