PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 7, 2016 Initiated: September 26, 2016 #Z-0666-2017

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Hamilton Medical, Inc.
Units Affected
44 units
Distribution
Nationwide Distribution
Location
Reno, NV

Frequently Asked Questions

What product 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.. Recalled by Hamilton Medical, Inc.. Units affected: 44 units.
Why was this product recalled?
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0666-2017.