Update: Use of GE HealthCare EVair and EVair 03 Compressors – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is issuing an update to inform the healthcare community of a change in recommendations for the GE HealthCare EVair Compressor.

In October 2024, GE HealthCare issued an updated recall notice based on final testing results, which demonstrated that formaldehyde emissions are below the safety threshold set for the intended patient population when using the EVair Compressor. EVair Compressors can be used to supply air to Carescape R860 ventilators for all patient populations, including neonatal and infant patients (0-2 years of age), and can be used in a room with maximum air temperature of 40 degrees C (104 degrees F).

No new/unused EVair 03 (Jun-Air) devices were available for final testing. Therefore, the previous recommendations for EVair 03 have not changed and continue to apply.

The Letter to Health Care Providers includes important information about the updated recall and use of these devices including:

• Updated Recommendations for EVair Compressors.
• Continued Recommendations for EVair 03 (Jun-Air) Compressors.
• The FDA’s actions to address the issue.
• Instructions for reporting problems with a device.

Questions?

If you have questions about this recall update, contact GE HealthCare Service or your local Service Representative at 1-800-437-1171.