GE HealthCare Recalls Giraffe OmniBed Carestations Due to Door Screw Issue
GE HealthCare is recalling certain Giraffe OmniBed Carestations because a screw securing the heater doors may not be torqued to specification, potentially causing the doors to become loose.
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: The recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.
Plain-English summary
GE HealthCare is recalling certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, including the Model Number 2082844-001-XXX. The recall involves a manufacturing issue where the screw that secures the doors covering the warmer heaters may not have been torqued to the required specification.
This defect may lead to the doors becoming loose. The source text does not specify the number of units affected, the specific dates of manufacture, or the geographic distribution beyond noting worldwide distribution in the metadata. No illnesses or injuries have been reported in the source text.
Healthcare facilities should contact GE HealthCare for instructions on how to address this issue. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death, although the specific mechanism of harm is not detailed in the provided text.
The recalled product
- Product
- GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
- Manufacturer
- DATEX--OHMEDA, INC.
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 models
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by DATEX--OHMEDA, INC. 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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