DATEX--OHMEDA, INC. recalls
2 recalls on record · 2 rated Critical · FDA
Every recall we have on record for DATEX--OHMEDA, INC., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)…
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.
GE Heathcare Giraffe OmniBed; neo natal incubator
GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.