Giraffe OmniBed incubator canopy fasteners can fall into patient compartment
Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.
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: FDA Class II recall with a stated risk of patient injury from parts falling into an infant's compartment, a risk of harm with no injuries reported.
Plain-English summary
The Giraffe OmniBed, a combination infant incubator and infant warmer, is being recalled across all models. The action covers 19,587 units, identified by the serial numbers in the recall notice.
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, and a fastener could fall into the patient compartment. According to the manufacturer, in rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach, and these conditions could potentially result in patient injury. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The devices are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the serial numbers in the recall notice and follow the instructions issued by GE HealthCare.
The recalled product
- Product
- Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 19,587
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, 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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