This recall 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.
Affected 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 Updated 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; Updated on October 11, 2024
What to Do
On December 29, 2023, 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.
On October 11, 2024, GE HealthCare sent all affected customers an update to the Urgent Medical Device Correction based on final testing for the EVair 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 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).
Reason for Recall Update
GE HealthCare is updating recommended actions for EVair compressors based on final testing results. 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).
The recommended actions have not changed for EVair 03 (Jun-Air) compressors because this version of the device has not been manufactured for more than seven years. There are no new or unused EVair 03 (Jun-Air) devices available for testing.
The use of the affected EVair 03 (Jun-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.
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 airsupply to the system, ensure that a compressed oxygen supply is also connected.
Contact Information
Customers in the U.S. with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
Additional Resources:
Additional Company Resources:
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.
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Content current as of:
10/29/2024
