Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ Recalled by Datex-Ohmeda, Inc. Due to GE HealthCare has become aware of elevated levels...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datex-Ohmeda, Inc. directly.
Affected Products
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;
Quantity: 1294 units
Why Was This Recalled?
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
Where Was This Sold?
Worldwide
About Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report