GE Healthcare is recalling some Carescape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values, according to an alert from the FDA.
The products 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.
The FDA has labeled this a Class I recall, as use of these devices may cause serious injuries or death. While there have been no reported injuries or deaths, the incorrectly displayed oxygen values could lead to hyperoxia or hypoxia, with the potential for organ damage, tissue injury, increased chance of infection, or death, according to the FDA.
Recalled Products:
- 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)
- Serial numbers:
- Airway Gas Option N-CAiO Serial Numbers
- CARESCAPE Respiratory Module E-sCO Serial Numbers
- CARESCAPE Respiratory Module E-sCOVX Serial Numbers
- CARESCAPE Respiratory Module E-sCAiO Serial Numbers
- CARESCAPE Respiratory Module E-sCAiOV Serial Numbers
- CARESCAPE Respiratory Module E-sCAiOE Serial Numbers
- CARESCAPE Respiratory Module E-sCAiOVE Serial Numbers
- Manufacturing Dates: June 7, 2019 to August 16, 2019
- Distribution Dates: June 7, 2019 to August 16, 2019
- Devices Recalled in the U.S.: 165
- Date Initiated by Firm: September 27, 2019
Healthcare providers using the GE Healthcare Carescape Respiratory Modules and Airway Gas Option monitoring equipment are instructed to do the following, as September 27, 2019 letter from GE Healthcare:
- 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.
The FDA directed customers with questions to contact GE Healthcare Service at 1-800-437-1171 or their local service representative.
