FDADecember 26, 2023device

GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

What to do

FDA enforcement status: Ongoing

Brands named

wipro ge healthcare privatewiprowipro ge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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