GE Healthcare respiratory modules issued FDA Class I recall due to incorrect oxygen values

Feb. 5, 2020

The U.S. Food and Drug Administration (FDA) has identified a Class I recall of the GE Healthcare CARESCAPE Respiratory Modules and Airway Gas Option. These are respiratory accessories designed for use with patient monitors and ventilators to measure respiratory gases (such as oxygen and carbon dioxide), anesthesia, and breathing characteristics in adults, pediatric, and neonatal patients. A Class I recall is the most serious type of recall because use of these devices may cause serious injuries or death.

GE Healthcare is recalling the CARESCAPE Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values which could lead to high (hyperoxia) or low (hypoxia) blood oxygen levels in the patient. The use of the affected product may cause long-term high or low blood oxygen levels, which could result in organ damage, tissue injury, increased chance of infection, or death. The affected modules can be used with other GE Healthcare monitoring equipment.

Recalled products include: Airway Gas Option N-CAiO (00840682104074) and CARESCAPE Respiratory Modules E-sCO (00840682104173), sCOVX (00840682104289, E-sCAiO (00840682104180), E-sCAiOV (00840682104142), E-sCAiOE (00840682104135), E-sCAiOVE (00840682104302).

On September 27, 2019, GE Healthcare sent a letter to customers informing them of the affected models and provided the following instructions:

·        Replace the affected respiratory modules with another module that is not affected by the issue. GE Healthcare will provide a replacement at no cost.

·         Ensure that respiratory modules are within specification, if they don't have a replacement, following the provided safety instructions.

·         Complete the provided form and return the form to GE Healthcare within 30 days from receipt.

Additionally, the FDA is informing customers to be aware that the modules can deteriorate over time. Customers should check that the modules are within specification using the provided instructions on at least a daily basis.

FDA has the announcement