Z-0959-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- December 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1465 units
Product Description
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
ALL SERIAL NUMBERS