Federal health officials indicate that some GE Healthcare respiratory monitors may display inaccurate patient oxygen levels, which could increase the risk of organ damage, infection or death.
A CARESCAPE Respiratory Module recall was announced by the FDA on February 4, due to a manufacturing defect that may cause the devices to display incorrect oxygen values, leading to high or low blood oxygen levels in the patient. No injuries or deaths have been linked to the recalled monitors, according to the agency.
The CARESCAPE Respiratory Modules and Airway Gas Options are respiratory accessories used in the healthcare setting to monitor adults, pediatric and neonatal ventilation activity. The devices measure respiratory gases such as oxygen and carbon dioxide, anesthesia, and breathing characteristics to ensure patients are receiving the appropriate course of treatment.
According to the recall, a defect in the design of the monitoring devices could calculate and display incorrect oxygen values, causing long-term high or low blood oxygen levels. The agency warns these incidents could result in serious adverse health consequences for patients including organ damage, tissue injury, increased chance of infection, or death.
The recall includes Airway Gas Option N-CAiO, and CARESCAPE Respiratory Modules with model numbers E-sCO, sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOE, and E-sCAiOVE. The devices were manufactured by GE Healthcare of Chicago, Illinois from June 7, 2019 through August 16, 2019 and were distributed for sale to healthcare facilities across the United States.
The FDA warns customers that the medical devices can deteriorate over time, and should be checked on a daily basis to ensure the modules are within specification.
On September 27, 2019, GE Healthcare issued a medical device warning to customers informing them of the issue, with instructions on how to replace the impacted Airway Gas Option and CARESCAPE respiratory modules. GE provided customers instructions on how to request a replacement module if one was not available at no cost.
The FDA has classified the recall with a Class I status, indicating it is the most serious type of recall. Class I recalls involve products in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Customers with impacted CARESCAPE or Airway Gas Option modules are encouraged to contact GE Healthcare Services at 1-800-437-1171 for any further questions.