October 29, 2024
The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor.
Previously, on December 29, 2023, GE HealthCare issued an Urgent Medical Device Correction notice to inform users about the potential for elevated levels of formaldehyde based on preliminary testing when the EVair or EVair 03 (Jun-Air) optional compressors are used with the Carescape R860 or Engström Carestation/Pro ventilators, respectively.
On October 11, 2024, GE HealthCare issued an updated 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. As a result, GE HealthCare has concluded that the recommended actions indicated in the previous letter for EVair Compressors no longer apply.
No new/unused EVair 03 (Jun-Air) devices were available for final testing. Therefore, the previous recommendations for EVair 03 (Jun-Air) Compressors have not changed and continue to apply.
Recommendations
- Review the Urgent Medical Device Correction update from GE HealthCare for the EVair and EVair 03 (Jun-Air) Compressors, which includes model numbers and Unique Device Identifier (UDI) information.
- Updated Recommendations for EVair Compressors:
- 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).
- EVair Compressors can be used in a room with maximum air temperature of 40 degrees C (104 degrees F).
- Continued Recommendations for EVair 03 (Jun-Air) Compressors:
- Do not use EVair 03 (Jun-Air) Compressors to supply air to ventilators for neonatal and infant patients (0-2 years of age).
- The maximum room air temperature for use of EVair 03 (Jun-Air) Compressors is 30 degrees C (86 degrees F).
- If you have questions about this recall update, contact GE HealthCare Service or your local Service Representative at 1-800-437-1171.
- Report any issues with use of the compressors to the FDA.
Background
Compressors are optional accessories for ventilators and used when wall air is not available.
The EVair compressor is intended for use with a Carescape R860 ventilator as a supply of compressed air.
The EVair 03 (Jun-Air) compressor is intended for use with an Engstrom Carestation/Pro ventilator as a supply of compressed air.
FDA Actions
The FDA will continue to work with the manufacturer to monitor the postmarket performance of these devices. The FDA will keep the public informed if any significant new information becomes available.
| DATE | EVENT |
|---|---|
| October 29, 2024 | The FDA provided a recall update based on final GE HealthCare testing results, which demonstrated that formaldehyde emissions are below the safety threshold set for the intended patient population when using the EVair Compressor. |
| January 9, 2024 | The FDA issued a Letter to Health Care Providers about potential exposure to certain chemicals with use of GE HealthCare EVair and EVair03 Compressors with certain ventilators. |
Unique Device Identifier (UDI)
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems).
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any medical device. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
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Content current as of:
10/29/2024
