Summary: GE HealthCare has issued an update to the EVair Compressor recall, with new guidelines and testing results confirming safe usage across all patient groups, including infants. Specific recommendations apply to the EVair 03 (Jun-Air) due to its discontinued status and potential risks.

Key Takeaways:

  • Updated recall instructions permit EVair Compressor use for all patients, but EVair 03 (Jun-Air) has restrictions due to safety concerns.
  • The recall update emphasizes following new guidelines to prevent adverse health outcomes in ventilator use.

On Oct 11, 2024, GE HealthCare sent customers affected by an EVair Compressor recall an update to an Urgent Medical Device Correction it issued late last year.

GE HealthCare’s final testing has demonstrated that formaldehyde emissions are below the safety threshold set for the intended patient population when using the EVair Compressor. The EVair compressors may be used by all populations, including neonate and infant patients (0-2 years of age).

RELATED: FDA Classifies Philips, Baxter, and Zoll Ventilator Recalls as Class I

Initial Recall and Safety Concerns

Last year, GE HealthCare, on behalf of Datex-Ohmeda Inc, sent all affected customers an Urgent Medical Device Correction with action steps to take based on preliminary testing showing elevated levels of formaldehyde emissions found at high temperature and low gas flow conditions when these compressors are used with the CARESCAPE R860 or Engstrom Carestation or Pro ventilators.

There have been no reported injuries or reports of death associated with this issue.

The latest announcement involves updating recall instructions for using these devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

In the latest update, GE is recommending the following actions:

  • Refer to new recall instructions: because the actions in the previous 2023 letter for EVair Compressors no longer apply.
  • Ensure all potential users in your facility are made aware of this updated safety notification and the recommended actions.

Updated Recommended Actions for EVair Compressors

  • The 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).
  • The EVair Compressor can be used in a room with a maximum air temperature of 40°C (104°F).

Continued Recommended Actions for EVair 03 (Jun-Air) Compressors

  • Do not use EVair 03 (Jun-Air) to supply air to ventilators for neonatal and infant patients (0-2 years of age).
  • Keep the maximum room air temperature for use of EVair 03 (Jun-Air) compressors to 30°C (86°F).

Purpose of EVair and Jun-air Compressors

The EVair and Jun-air compressors are optional ventilator accessories intended to provide an alternative source of air flow for patient support for use in clinical scenarios where wall air is unavailable.

The EVair medical air compressor is intended to be connected to a Datex-Ohmeda critical care ventilator as a supply of compressed medical breathing air (compressed air). The ventilator must be operated with at least one additional supply of compressed medical breathing air or oxygen besides the EVair.

The EVair 03 compressor is intended for use as an optional accessory to Datex-Ohmeda critical care ventilators as a breathable compressed air supply. If the compressor is the primary airsupply to the system, ensure that a compressed oxygen supply is also connected.