GE Healthcare Lullaby Incubator bedside panels may fail to latch properly
GE Healthcare Lullaby Incubator bedside panels and portholes may appear closed but not be properly latched. If impacted, these panels can disengage and fall open, creating a fall risk for patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric rule, FDA Class I recalls must score no lower than 4 (Severe). Although no illnesses or injuries are reported in the source, the serious potential for patient harm from an unlatched incubator panel justifies the FDA's Class I designation.
Plain-English summary
GE Healthcare has identified a defect affecting bedside panels and portholes on multiple incubator models, including the Lullaby, Lullaby TR, and Lullaby XP Incubators. The panels and portholes may appear closed and latched, but the latching mechanism may not be fully engaged. The presence of a visible red indicator may create the false impression that a panel is properly secured when it is not.
If a patient impacts a bedside panel or porthole that is not properly latched, the panel can disengage and fall open. This removes the protective barrier of the incubator, creating a risk that a patient, particularly an infant, could fall.
This recall affects 17 units that have been distributed worldwide.
The recalled product
- Product
- GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Affected units
- 17
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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