Datex-Ohmeda recalls EvAir CPRSR Kit Upgrade models with serial numbers listed. Elevated formaldehyde levels observed in specific use conditions with certain ventilators, though not typical clinical use. No remedy provided.
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 specific EvAir CPRSR Kit Upgrade models due to potential elevated formaldehyde levels when used with certain ventilators under specific temperature and flow conditions. This risk is observed in preliminary testing but not representative of typical clinical use.
Elevated formaldehyde levels were observed in preliminary testing at high temperatures (40°C/104°F) and low flow conditions (2 L/min). These conditions are not typical in clinical use, but GE HealthCare is taking action to reduce potential patient exposure.
Healthcare providers using the recalled EvAir CPRSR Kit Upgrade models with specific ventilators (CARESCAPE R860 or Engström Carestation/Pro) are most at risk. The affected units have specific model numbers and serial numbers listed in the recall.
Check if your EvAir CPRSR Kit Upgrade has model numbers M1230847 or M1230849 with the listed serial numbers. The recall covers specific electrical configurations and models used with CARESCAPE R860 or Engström Carestation/Pro ventilators.
Verify your EvAir CPRSR Kit Upgrade model number and serial numbers against the list provided in the recall.
No, the elevated formaldehyde levels were observed only under specific test conditions (high temperature and low flow), not typical clinical use. GE HealthCare states this action is to further reduce potential exposure.
The recall does not provide a remedy. You should check your product details against the list of affected serial numbers to determine if you are affected.
Check the model number and serial numbers listed in the recall. Affected units have specific electrical configurations (M1230847 or M1230849) with the serial numbers provided in the document.
We’ve drafted a message you can send Datex-Ohmeda to request your refund or repair — edit it as you like.
Subject: Recall Z-0776-2024 — Datex-Ohmeda Datex-Ohmeda Hello, I own a Datex-Ohmeda that is covered by recall Z-0776-2024 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.
