GE Healthcare Giraffe infant incubator recalled for formaldehyde exposure

Plain-English summary

GE Healthcare Giraffe Omnibed Carestation CS1 infant incubator and warmer units are the subject of this recall, affecting 769 units manufactured under prior manufacturing practices and distributed worldwide.

Prior to current manufacturing standards, newly manufactured incubators could release elevated levels of airborne formaldehyde during clinical use. The formaldehyde exposure would rapidly decrease over approximately one week of operation. Sensory irritation of the eyes is identified as the most sensitive health effect at the lowest exposure concentrations.

The manufacturer notified affected customers in June 2023 to operate incubators for one week to allow potential off-gassing of residual airborne formaldehyde. Healthcare facilities should identify whether their incubators match the affected model numbers and batch codes listed in the official FDA recall notice and follow the manufacturer's off-gassing guidance.

The recalled product

Product

GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2

Manufacturer

DATEX--OHMEDA, INC.

Category

Medical Device — Neonatal / Pediatric Equipment

Hazard

• formaldehyde-exposure
• chemical-off-gassing
• eye-irritation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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