GE Healthcare Compact Airway Modules Recalled for Pump Failure Risk
GE Healthcare is recalling Compact Airway Modules because a loose screw may cause pump failure, leading to loss of respiratory gas monitoring.
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 where a defect could lead to the loss of critical patient monitoring. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or deaths are mentioned in the source text.
Plain-English summary
GE Healthcare, LLC is recalling specific models of Compact Airway Modules, including the E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, and E-CAiOVX. These devices are used in hospitals to monitor patients' respiration, ventilation, and gas exchange status. The recall involves 4,961 units, with 1,946 units distributed in the United States and 3,015 units distributed outside the US.
The recall is due to a potential defect where the gas sampling pump hex screw in the module pump unit may loosen. This loosening can lead to pump failure, which may cause a loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will display an alarm note on the screen indicating either "Low gas sample flow" or "Check sample gas out."
The affected units were distributed worldwide, including in most states in the continental USA (excluding DE, ME, ND, RI, and VT) and numerous international countries. Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice and contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
- Manufacturer
- GE Healthcare, LLC
Distribution
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