GE Healthcare Care Plus Incubator Hood Latching Defect Increases Fall Risk
GE Healthcare incubator hoods can appear closed but may not be properly latched, posing a fall risk if patients impact an unsecured panel.
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 applies. Although no incidents are currently reported, the agency's designation of Class I indicates a serious hazard with potential for adverse health consequences. The defect involves a failure mode that could result in patient falls.
Plain-English summary
GE Healthcare Care Plus Hood Field Replacement Unit kits, used in Care Plus, Lullaby, and Lullaby XP incubators, can have bedside panels and portholes that appear closed but are not properly latched. The red indicator may be visible even when the panel is not secured, and obstructed portholes may also appear closed while unlatched. Approximately 1,465 units have been distributed worldwide, affecting all serial numbers of the part numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, and 6600-0083-850.
If a patient impacts an unlatched panel or porthole, it can disengage and fall open, removing the protection against patient falls. The FDA has classified this as a Class I recall due to the serious patient safety risk posed by the latching defect.
The recalled product
- Product
- 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
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Category
- Medical Device — Incubator
- Hazard
- Affected units
- 1,465
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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