On Jan. 9, the FDA issued a Letter to Health Care Providers to alert providers and facilities about the potential for exposure to certain chemicals that may be released when General Electric (GE) HealthCare accessory components called the EVair or Evair03 compressor are used with certain ventilators, and to help ensure providers are aware of the manufacturer’s recall notice and recommended actions.
On December 29, 2023, GE HealthCare issued an Urgent Medical Device CorrectionExternal Link Disclaimer 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. GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde.
The FDA is not aware of reports of adverse events due to this issue to date.
FDA has the full letter.
