Reported Dec 7, 2016 · Terminated

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support…

Hamilton Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical, Inc. · 4990 Energy Way · Reno, NV · 89502-4123

Is this the product you have?

  • Hamilton-MR1 VentilatorCatalog# 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 includeMRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital
Lot codes and dates
  • Serial Numbers between 2001 and 2103
Amount recalled
44 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 8, 2017 · Data as of Sep 19, 6:00 PM UTC

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