Datex-Ohmeda recalls EVair 03 (Jun-air) air compressors (models 1609000, 1609002) due to potential formaldehyde exposure when used with specific ventilators at high temperatures and low flow rates.
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.
Datex-Ohmeda is recalling EVair 03 (Jun-air) air compressors with model numbers 1609000 and 1609002. These compressors may release elevated formaldehyde levels when used with certain ventilators under specific conditions, potentially exposing patients to harmful levels of formaldehyde.
Elevated formaldehyde levels were detected in preliminary testing when the compressors were used with specific ventilators at high temperatures (40°C/104°F), low flow rates (2 L/min), and with no supplemental oxygen. While these conditions are not typical clinical use, the potential for formaldehyde exposure exists.
Healthcare providers using the EVair 03 (Jun-air) compressors with GE HealthCare's CARESCAPE R860 or Engström Carestation/Pro ventilators are most at risk. Patients receiving care through these systems could be exposed to elevated formaldehyde levels under specific conditions.
Check for model numbers 1609000 or 1609002 on the EVair 03 (Jun-air) air compressors. The serial numbers listed in the recall include CBCS01269, CBCT02328, and other similar codes.
Identify the model number on your EVair 03 (Jun-air) air compressor to see if it matches 1609000 or 1609002.
GE HealthCare detected elevated formaldehyde levels in preliminary testing when these compressors were used with specific ventilators under high temperatures and low flow conditions.
Patients using these compressors with specific ventilators could be exposed to elevated formaldehyde levels under specific conditions, though these conditions are not typical clinical use.
The recall does not specify a remedy, so check the model number to see if it is affected and contact Datex-Ohmeda for further guidance.
We’ve drafted a message you can send Datex-Ohmeda to request your refund or repair — edit it as you like.
Subject: Recall Z-0775-2024 — Datex-Ohmeda Datex-Ohmeda Hello, I own a Datex-Ohmeda that is covered by recall Z-0775-2024 from Datex-Ohmeda. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
