Product Wiki · Recalls · U.S. FDA — Device Enforcement

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator… — recall Z-0666-2017

U.S. FDA — Device Enforcement · United States · 2016-09-26 · Class II

As described by U.S. FDA — Device Enforcement: 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 tr

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0666-2017
Date of alert
2016-09-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hamilton Medical, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution
Reported risk: Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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