Events

Recall of HamiltonMR1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hamilton Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75336
  • Event Risk Class
    Class 2
  • Event Number
    Z-0666-2017
  • Event Date Posted
    2016-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150064
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    Oxygen tubing and the oxygen connector of the hamilton-mr1 could potentially become loose during the preparation for ventilation.
  • 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 upgrade kit to be installed. Customers with questions should call 817-909-0308.

Device

HamiltonMR1
  • Model / Serial
    Serial Numbers between 2001 and 2103
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • 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.
  • Manufacturer
    Hamilton Medical, Inc.

Manufacturer

Hamilton Medical, Inc.
  • Manufacturer Address
    Hamilton Medical, Inc., 4990 Energy Way, Reno NV 89502-4123
  • Manufacturer Parent Company (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA