Hamilton Medical, Inc. recalls Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support…

Recall date

September 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0666-2017

FDA classification

Class II

Brand / firm

Hamilton Medical, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.

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-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.