Events

Recall of Device Recall HamiltonG5 Ventilator

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
    61238
  • Event Risk Class
    Class 2
  • Event Number
    Z-1185-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107632
  • 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
    Hamilton-g5 ventilators with software version v2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.
  • Action
    Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.

Device

Device Recall HamiltonG5 Ventilator
  • Model / Serial
    All Hamilton 5
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.
  • Product Description
    HAMILTON G5 ventilators with software version V2.0x. || Hamilton Medical AG, Switzerland || Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. || Product Usage: || Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Manufacturer Address
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-3008
  • Manufacturer Parent Company (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA