GE HealthCare Announces Revisions to EVair Compressors Following Recent Formaldehyde Testing Outcomes

GE HealthCare Announces Revisions to EVair Compressors Following Recent Formaldehyde Testing Outcomes

This recall pertains to updated guidance for utilizing certain devices and does not necessitate their removal from usage or sales locations. The FDA classifies this recall as the most critical category. Non-compliance with the revised instructions could lead to serious injury or fatalities.

Products Concerned

  • Product Names:
    • EVair air compressors (model numbers M1230849, M1230847)
    • EVair-03 air compressors (Jun-air; model numbers 1609000, 1609002)
    • EvAir CPRSR Kits (model numbers M1230849, M1230847)
  • Product Codes: Refer to Updated Recall Database Entry
  • Distribution Dates: September 1, 2013 to November 16, 2023
  • Recalled Devices in the U.S.: 511
  • Date the Firm Initiated Recall: November 15, 2023; Updated October 11, 2024

Recommended Actions

On December 29, 2023, GE HealthCare, on behalf of Datex-Ohmeda Inc., informed all impacted customers about urgent medical device corrections, detailing necessary actions following preliminary tests that indicated increased levels of formaldehyde emissions under specific conditions when these compressors are coupled with the CARESCAPE R860 or Engstrom Carestation/Pro ventilators.

On October 11, 2024, GE HealthCare provided customers with updates on the Urgent Medical Device Correction, based on final test results for the EVair, advising the following steps:

  • Refer to the new recall instructions, as the previous 2023 instructions for EVair Compressors are now outdated.
  • Ensure that all potential users within your facility are informed of this updated safety notice and recommended actions.

New advised actions for EVair Compressors:

  • EVair Compressors are suitable for use with CARESCAPE R860 ventilators for all patient groups, including neonates and infants (0-2 years old).
  • The EVair Compressor can be utilized in environments with a maximum air temperature of 40°C (104°F).

Ongoing recommended actions for EVair 03 (Jun-Air) Compressors:

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

Reason for Recall Update

GE HealthCare’s updated actions for EVair compressors are informed by final testing outcomes, which confirmed that formaldehyde emissions are now within safety limits for the target patient demographic when using the EVair Compressor. Thus, it is appropriate for use across all populations, including neonates and infants (0-2 years).

For the EVair 03 (Jun-Air) compressors, the recommended actions remain unchanged, as this model has not been produced in over seven years, and no new units are available for evaluation.

Employing the EVair 03 (Jun-Air) compressor could potentially result in severe health effects, including airway irritation or inflammation, leading to airway hyperresponsiveness, particularly in newborns or infants.

No injuries or fatalities linked to this issue have been reported.

Device Specifications

The EVair and Jun-air compressors serve as optional ventilator accessories, designed to provide an alternative air flow source for patient support in scenarios where wall air is unavailable.

The EVair medical air compressor is meant for supplying compressed medical air to Datex-Ohmeda Inc.’s critical care ventilator [CARESCAPE R860]. It must be used with at least one additional air or oxygen source alongside the EVair.

The EVair 03 compressor is an optional accessory for Datex-Ohmeda critical care ventilators [Engstrom Carestation/Pro], providing breathable compressed air. If used as the main air supply, ensure an oxygen source is also connected.

Contact Details

U.S. customers with questions regarding this recall should reach out to GE HealthCare Service at 1-800-437-1171.

Additional Resources:

Company Information:

How to report issues?

Healthcare providers and consumers may report any adverse events or quality concerns experienced with these devices via MedWatch: The FDA’s Safety Information and Adverse Event Reporting Program, through an online form, standard mail, or fax.