FDA Device recall Z-0958-2024
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
- FDA Device
- Class I
- ongoing
- Published 2024-02-21
On 2024-02-21 the FDA classified a Class I recall of GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR by Wipro Ge Healthcare Private, citing 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 I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0958-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-26 |
| Published | 2024-02-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wipro Ge Healthcare Private |
| Distribution | n/a |
Product
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
Reason
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.
Identifiers
| code_info | a) Lullaby Incubator, Model Numbers: M1151042, QCR031; b) Lullaby Incubator XP, Model Numbers: 8320, M1151135, QCR0…a) Lullaby Incubator, Model Numbers: M1151042, QCR031; b) Lullaby Incubator XP, Model Numbers: 8320, M1151135, QCR034; c) Lullaby Incubator TR, Model Numbers: M1151357 ALL SERIAL NUMBERS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2024%22
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