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Hamilton Medical, Inc. recalls HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults a
Recalled August 2, 2023 · FDA recall Z-2139-2023 · Hamilton Medical
Hazard
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice. · FDA Class I
Units
689 systems
Sold at
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Description
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Product
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Manufacturer(s)
Hamilton Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →