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.
- Company
- Hamilton Medical Inc
- Recall Initiated
- September 26, 2016
- Posted
- November 28, 2016
- Terminated
- March 8, 2017
- Recall Number
- Z-0666-2017
- Quantity
- 44 units
- Firm Location
- Reno, NV
Reason for Recall
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Distribution
Nationwide Distribution
Lot / Code Info
Serial Numbers between 2001 and 2103
Root Cause
Device Design
Action Taken
Hamilton Medical sent a letter dated September 6, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Hamilton Medical will update each affected Hamilton-MR1 ventilators by installing a new oxygen mixer mounting plate with the correct screws at no cost to each facility. A Hamilton Medical Field Service Technician will contact customers soon to schedule a convenient time to install the hardware upgrade. Customers may also call 1-800-426-6331, option #2 to be issued an RGA for return to the service center for the upgrade kit to be installed. Customers with questions should call 817-909-0308.