GE Healthcare recalls Lullaby Incubator Model Hood FRU kits due to potential panel disengagement if not latched, risking patient falls. Affected units include Care Plus models 1000-4000 and Lullaby series.
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.
GE Healthcare is recalling Lullaby Incubator Model Hood FRU kits that may not be properly latched even when appearing closed. This could cause the panel to disengage and fall open, potentially allowing a patient to fall.
The bedside panel and portholes may look closed but not be securely latched when the red indicator is visible or when hood covers obstruct them. If a patient impacts an unlatched panel or porthole, it can disengage and fall open, creating a fall hazard.
Parents or caregivers of infants using GE Healthcare Lullaby Incubators with the recalled Model Hood FRU kits. Infants in incubators are most at risk if the panel disengages.
Check for the Model Hood FRU kit with part numbers M1169566, M1160659, M1206259, M1206260, M1166836, or M1166814. All units with these part numbers are affected regardless of serial number.
Look for the red indicator light to see if the panel is latched properly; if visible, the panel may not be secure.
Confirm the Model Hood FRU kit part numbers match the listed ones: M1169566, M1160659, M1206259, M1206260, M1166836, or M1166814.
The bedside panel and portholes may appear closed but not be latched when the red indicator is visible or when hood covers obstruct them, risking panel disengagement and patient falls.
Check if your Model Hood FRU kit has the listed part numbers. If so, ensure the panel is latched properly by checking for the red indicator light. If the panel appears closed but the red indicator is visible, it may not be secure.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0961-2024 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0961-2024 from GE Healthcare. 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.
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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.
