FDA-Device2016-12-07Class II
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.
Hamilton Medical, Inc.
Hazard
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Sold states
Nationwide Distribution
Affected count
44 units
Manufactured in
4990 Energy Way, Reno, NV, United States
Products
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2017Don't want to check this manually?
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