GE Healthcare incubator bedside panel may disengage and fall open
The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.
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 recall of a critical medical device protecting vulnerable neonatal patients. The hazard is a structural latching failure that could result in the protective panel falling open and exposing patients to injury from falling, representing a serious risk of harm.
Plain-English summary
GE Healthcare is recalling the Care Plus Hood Door FRU kit (part numbers 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500) used in Care Plus Model 1000, 2000, 3000, and 4000 Incubators, as well as Lullaby, Lullaby TR, and Lullaby XP Incubators. The bedside panel can remain unlatched while appearing to be closed, especially when the red indicator is visible or when portholes are obstructed.
If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open. This loss of the protective barrier exposes the patient to the risk of falling.
The recall affects approximately 1,810 units distributed worldwide. Affected facilities should immediately verify that all incubator panels and portholes are properly latched before patient use and contact GE Healthcare with any questions or concerns.
The recalled product
- Product
- GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Hazard
- structural-failure
- latching-failure
- fall-risk
- patient-injury-risk
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.
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