GE Healthcare Care Plus and Lullaby incubators recalled for bedside panel latching defect
GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.
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: This is an FDA Class I medical device recall of neonatal incubators with latching mechanism failure. The defect creates risk of patient falls if bedside panels disengage while unlatched. No injuries reported to date, but FDA Class I classification indicates serious potential harm.
Plain-English summary
GE Healthcare is recalling neonatal incubators due to a latching defect on bedside panels and portholes. The affected models are Care Plus (Models 1000, 2000, 3000, and 4000), Lullaby Incubator, Lullaby TR Incubator, and Lullaby Incubator XP. A total of 1,410 units have been distributed worldwide.
The bedside panel and portholes can appear closed and latched but may not actually be secured. A red indicator is designed to show latching status, but the indicator can be visible while the panel or porthole remains unlatched. Portholes may also appear visually closed when obstructed by hood covers or other objects, even when they are not actually latched.
If a patient impacts the bedside panel or porthole while it is not actually latched, the panel can disengage and fall open. When this occurs, the protective barrier provided by the panel no longer prevents the patient from falling.
The recalled product
- Product
- GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Affected units
- 1,410
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 (9)
- 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
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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