Recall Z-0666-2017 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
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.
| Date | Nov 28, 2016 (initiated Sep 26, 2016) |
| Status | Terminated |
| Reason | Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation. |
| Root cause | Device Design |
| Action | 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 upgrad |
| Quantity | 44 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122438 | HAMILTON-MR1 Hamilton Medical AG, Nov 20, 2013 |