[pending] Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Pending LLM rewrite. Source: FDA_DEVICE Z-2475-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
The recalled product
- Product
- Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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