GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
Publicado el 21 de febrero de 2024 · Inicio del retiro: 26 de diciembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Wipro GE Healthcare Private Ltd.
- Distribuidor
- Worldwide distribution.
- Lote
- 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
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- India
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