Events

Recall of Device Recall The HAMILTON T1

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
    64117
  • Event Risk Class
    Class 1
  • Event Number
    Z-0741-2013
  • Event Initiated Date
    2012-12-19
  • Event Date Posted
    2013-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115383
  • 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
    Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a hamilton t1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
  • Action
    Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215

Device

Device Recall The HAMILTON T1
  • Model / Serial
    Software Versions 1.1.2 and below; Part numbers 161005, 161006.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the country of Switzerland.
  • Product Description
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. || The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Manufacturer Address
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-4123
  • Manufacturer Parent Company (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA