The FDA has alerted healthcare providers about potential exposure to elevated levels of formaldehyde when GE Healthcare accessory components called the EVair or EVair 03 (Jun-air) compressors are used with certain ventilators.

On December 29, 2023, GE Healthcare issued an Urgent Medical Device Correction to inform users about the potential for elevated levels of formaldehyde based on preliminary testing when the EVair or Jun-Air optional compressors are used with the Carescape R860 or Engström Carestation/Pro ventilators, respectively.

The EVair compressor is intended for use with a Carescape R860 ventilator as a supply of compressed air. The EVair03 (Jun-Air) compressor is intended for use with an Engstrom Carestation/Pro ventilator as a supply of compressed air. 

Exposure to elevated levels of formaldehyde may lead to problems such as neurological impairment or respiratory problems (such as asthma, decreased lung function, inflammation, or irritation), which is particularly concerning for neonates and infants (0-2 years of age) who may have immature pulmonary function or other coexisting conditions. 

According to the FDA alert, the agency is not aware of reports of adverse events due to this issue to date and says GE Healthcare is continuing to evaluate the root cause for these elevated levels of formaldehyde. 

FDA Recommendations

The FDA issued the following recommendations:

  • Review the Urgent Medical Device Correction notice from GE HealthCare for the EVair and EVair 03 (Jun-Air) Compressors, which includes model numbers and Unique Device Identifier (UDI) information.
  • Do not use EVair and EVair 03 (Jun-Air) compressors to supply air to ventilators for neonatal and infant patients (0-2 years of age).
  • Be aware that GE HealthCare is lowering the maximum room air temperature for operation of the compressors from 40 degrees C (104 degrees F) to 30 degrees C (86 degrees F) to further reduce the potential for patient exposure to formaldehyde.
  • Be aware that GE HealthCare is updating user instructions with the updated operating conditions (30 degrees C (86 degrees F) maximum room air temperature) and indications for use specifying that the compressors are not recommended for use with neonates and infants (0-2 years of age).
  • Report any issues with use of the compressors to the FDA.

Source: FDA