FDA-Device2024-02-21Class I
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
Wipro GE Healthcare Private Ltd.
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.
Sold states
Worldwide distribution.
Affected count
1 unit
Manufactured in
122 Part 1, Odyssey And Galileo, Bengaluru, N/A, India
Products
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2024Don't want to check this manually?
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