GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)… Recall
Issued November 6, 2024 · DATEX--OHMEDA, INC.
In November 2024, DATEX--OHMEDA, INC. recalled the GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
What you should do
- 1 Stop using GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact DATEX--OHMEDA, INC. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- DATEX--OHMEDA, INC.
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- Sold at
- worldwide
- Recall number
- FDA-Z-0141-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- DATEX--OHMEDA, INC. has 2 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.