The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- 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: See Recall Database Entry
- Distribution Dates: September 1, 2013 to November 16, 2023
- Devices Recalled in the U.S.: 511
- Date Initiated by Firm: November 15, 2023
Device Use
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 (EVair) is intended to be connected to a Datex-Ohmeda Inc. critical care ventilator [CARESCAPE R860] 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 [Engstrom Carestation/Pro] as a breathable compressed air supply. If the compressor is the primary air supply to the system, ensure that a compressed oxygen supply is also connected.
Reason for Recall
Datex-Ohmeda Inc. is recalling the EVair and Jun-air compressors due to 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.
The use of the affected air compressor may cause serious adverse health consequences, including airway irritation or inflammation that could potentially lead to airway hyperresponsiveness in newborns or infants.
There have been no reported injuries or reports of death associated with this issue.
Who May be Affected
- People who are treated in a health-care setting using the EVair and Jun-air compressors.
- The EVair compressor is not intended for use with neonatal or infant patients, age 0 to 2 years.
- Health care personnel who use EVair and Jun-air compressors to treat patients.
What to Do
On December 29, 2023, GE HealthCare sent all affected customers an Urgent Medical Device Correction.
The letter requested customers to:
- Not use supply air to ventilators for neonatal and infant patients (0-2 years of age).
- Keep the maximum room air temperature for operation of the compressors to 30oC (86oF).
- Ensure all potential users in your facility are made aware of this safety notification and the recommended actions.
- Retain the Urgent Medical Device Correction and the Addendum to the user instructions for your records. Users should keep a copy of the Addendum available near the areas where the compressors are used.
- Complete and return the attached acknowledgement form to Recall_FMI_34134@ge.com.
Contact Information
Customers in the U.S. with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
Additional Resources:
- Class 1 Device Recall DatexOhmeda (fda.gov) – EVair air compressor
- Class 1 Device Recall DatexOhmeda (fda.gov) – EVair 03 (Jun-air) air compressor
- Class 1 Device Recall DatexOhmeda (fda.gov) – CPRSR Kit
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
