Medical device recalls Moderate risk

Hamilton Medical AG recalls Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and…

Recall date
March 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1371-2018
FDA classification
Class II
Brand / firm
Hamilton Medical AG
Sold / distributed
Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Austria, Azerbaijan, Bangladesh, Belarus, Bel…

Why it was recalled

After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

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