GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen
Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.
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: This is an FDA Class I medical device recall, which establishes a minimum severity of 4 per the rubric. Although no injuries or illnesses have been reported, the potential for doors to loosen on neonatal incubation equipment presents a safety concern in a critical care environment.
Plain-English summary
GE HealthCare Giraffe OmniBed and Giraffe OmniBed Carestation neonatal incubators are subject to a Class I recall. The manufacturer has identified that certain units may have doors covering the warmer heaters that are not properly secured due to screws that were not torqued to specification.
If the screws are not properly torqued, the doors covering the warmer heaters may become loose during operation. This creates a potential safety hazard in a neonatal intensive care setting.
The recall affects certain Giraffe OmniBed and Giraffe OmniBed Carestation units that have been distributed worldwide.
The recalled product
- Product
- GE Heathcare Giraffe OmniBed; 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.
See all 2 products in this recall →Related recalls
Same manufacturer · DATEX--OHMEDA, INC.
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