GE Healthcare Ventilators Recalled for Caster Mounting Hardware Failure Risk
GE Healthcare is recalling specific ventilator models due to a potential failure of the caster mounting hardware that could cause the device to fall or tip over.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury from a falling device.
Plain-English summary
GE Healthcare is recalling the Engstrom Carestation, Engstrom Pro, and Cart Only S/5 EC ventilators, identified by GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. The recall involves 3,213 units, with 437 units distributed in the United States and 2,776 units distributed outside the US.
The recall is being conducted because of a potential failure of the caster mounting hardware. This defect may result in the ventilator falling or tipping over (overbalancing). The affected units were distributed worldwide, including in the US and numerous international locations.
Healthcare facilities and consumers should check their ventilator model and serial numbers against the list provided by the FDA. If a unit is affected, it should be removed from service and the manufacturer contacted for further instructions.
The recalled product
- Product
- GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Ventilator
Distribution
Distributed nationwide across the United States.
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