Important Update: Communication to Health Care Providers Regarding GE HealthCare EVair and EVair 03 Compressors

October 29, 2024

The U.S. Food and Drug Administration (FDA) is providing an update for the healthcare industry regarding modifications in recommendations concerning the GE HealthCare EVair Compressor.

On December 29, 2023, GE HealthCare issued an Urgent Medical Device Correction notice alerting users of the possibility of heightened formaldehyde levels revealed by initial testing when using EVair or EVair 03 (Jun-Air) optional compressors with either the Carescape R860 or the Engström Carestation/Pro ventilators.

However, on October 11, 2024, GE HealthCare published an updated notice reflecting final testing results that showed formaldehyde emissions are now below the safety limit established for the intended patient demographic when utilizing the EVair Compressor. Consequently, GE HealthCare determined that the previously outlined actions for EVair Compressors are no longer necessary.

It should be noted that no new or unused EVair 03 (Jun-Air) units had undergone final testing, so the previous guidelines for EVair 03 (Jun-Air) Compressors remain unchanged and continue to be in effect.

Recommendations

• Examine the Urgent Medical Device Correction update from GE HealthCare concerning the EVair and EVair 03 (Jun-Air) Compressors, which provides details on model numbers and Unique Device Identifier (UDI) information.
• Updated Recommendations for EVair Compressors:
  • EVair Compressors are now suitable for supplying air to Carescape R860 ventilators for all patient groups, including neonates and infants (0-2 years old).
  • EVair Compressors can be utilized in an environment with a maximum air temperature of 40 degrees C (104 degrees F).
• Ongoing Recommendations for EVair 03 (Jun-Air) Compressors:
  • Avoid using EVair 03 (Jun-Air) Compressors to provide air to ventilators for neonate and infant patients (0-2 years of age).
  • The maximum room temperature for operating EVair 03 (Jun-Air) Compressors is 30 degrees C (86 degrees F).
• For inquiries regarding this recall update, contact GE HealthCare Service or your local Service Representative at 1-800-437-1171.
• Report any concerns related to the use of the compressors to the FDA.

Background

Compressors serve as optional accessories for ventilators and are essential when wall air supply is unavailable.

The intention of the EVair compressor is to work with a Carescape R860 ventilator as a source of compressed air.

Conversely, the EVair 03 (Jun-Air) compressor is designated for use alongside an Engstrom Carestation/Pro ventilator as a compressed air supply.

FDA Actions

The FDA intends to sustain its collaboration with the manufacturer to observe the ongoing performance of these devices after their market introduction. The agency will inform the public of any consequential new developments.

Unique Device Identifier (UDI)

The FDA has implemented the unique device identification system to effectively identify medical devices sold in the U.S. from production through distribution to patient application. For more details regarding UDI, please visit Unique Device Identification System (UDI Systems).

Reporting Problems to the FDA

The FDA strongly encourages healthcare professionals to report any negative events or potential adverse occurrences related to any medical device. Timely reporting can enable the FDA to recognize and comprehend the risks related to medical devices and enhance patient safety.

Contact Information

For additional questions regarding this letter, please contact the Division of Industry and Consumer Education (DICE).