Official recall record
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-12-26
- Country of alert
- India
- Alert level
- Class I
- Alert type
- recall
- Brand on record
- Wipro GE Healthcare Private Ltd.
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
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GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 586 - 2024-08-09 · US FDA — Medical Devices
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All 6 official recall notices naming Wipro GE Healthcare Private Ltd. on this site →