GE Healthcare Incubators Bedside Panel Latch Failure Poses Fall Risk
GE Healthcare incubators have defective bedside panels that may appear closed but not be properly latched, creating a patient fall risk when the panels disengage upon impact.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for this device defect establishes a minimum Severe rating. The defect involves failure of a physical protection mechanism, creating serious fall risk in a vulnerable patient population despite no illnesses currently reported.
Plain-English summary
GE Healthcare Lullaby and Care Plus series incubators have a latching defect affecting the bedside panel and portholes. These components can appear fully closed while remaining unlatched, particularly when portholes are obstructed by hood covers or other barriers.
If a patient impacts an unlatched panel or porthole, the defective mechanism can fail, causing the panel to disengage and fall open. This eliminates the physical protection the panel is designed to provide and creates a serious fall risk for vulnerable patient populations.
Healthcare facilities using affected incubators should inspect the bedside panels and portholes to verify proper latching. Contact the manufacturer or refer to the FDA recall notice for inspection and repair procedures to ensure patient safety.
The recalled product
- Product
- GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL SERIAL NUMBERS
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Wipro GE Healthcare Private Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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