GE Healthcare Recalls Giraffe Infant Warmers Due to Latching Defect
GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
GE Healthcare, LLC is recalling approximately 19,425 units of Giraffe Incubator infant warmers, including the Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation. The recall is due to a defect where bedside panels and portholes can appear closed without being properly latched.
This defect creates a potential risk of patient falls. The affected units were distributed worldwide. The recall covers specific model numbers, including 6651-XXXX-XXX, 2074921-00X-XXXXXX, and various M-series model numbers. An update to the recall indicates that all model numbers and units are affected.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The U.S. Food and Drug Administration has classified this as a Class I recall, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Giraffe Incubator infant warmer
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Infant Warmers
- Affected units
- 19,425
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE Healthcare, LLC 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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