GE Healthcare Recalls Giraffe Incubator Carestations Due to Latch Defect
GE Healthcare is recalling Giraffe Incubator Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall."
Plain-English summary
GE Healthcare, LLC is recalling 3,467 units of Giraffe Incubator Carestation and Giraffe Incubator Carestation CS1 infant warmers. The recall covers units distributed worldwide, including specific model numbers ending in XXXXXX.
The recall was issued because the bedside panels and portholes on these devices can appear closed without actually being latched. This defect creates a potential risk of patient falls.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.
The recalled product
- Product
- Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Infant Warmer
- Affected units
- 3,467
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)
- Giraffe Incubator Carestation
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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