GE Medical recalls Carestation 620 A2, 650 A2, and 650c A2 models with possible CO2 leak risk. Affected units have specific serial numbers and model codes.
Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
GE Medical is recalling certain Carestation 600 Series medical devices due to a possible incomplete seal between the CO2 absorber and breathing circuit. This could lead to CO2 leaks during use, potentially causing patient harm if not addressed.
The Carestation 600 Series devices may have a seal that doesn't close properly between the CO2 absorber and the breathing circuit CO2 bypass port. This could allow CO2 to leak into the patient's breathing circuit, potentially causing harmful levels of carbon dioxide in the patient's blood.
Healthcare facilities using the Carestation 620 A2, 650 A2, or 650c A2 models with the listed serial numbers and model codes are most at risk. Patients using these devices could be affected if the seal fails.
Check if your Carestation 620 A2, 650 A2, or 650c A2 has the model numbers 1012-9620-000, 1012-9650-000, or 1012-9655-000, and the listed serial numbers. The UDI numbers also match specific patterns.
Verify your Carestation model and serial numbers against the list provided in the recall notice.
The affected models are Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 with specific serial numbers and model codes listed in the recall notice.
Check your device's model number (1012-9620-000, 1012-9650-000, or 1012-9655-000) and serial number against the list provided in the recall notice.
The recall notice does not specify a remedy, so contact GE Medical directly for guidance on next steps.
We’ve drafted a message you can send GE Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0580-2018 — GE Medical GE Medical Hello, I own a GE Medical that is covered by recall Z-0580-2018 from GE Medical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
