Events

Recall of Device Recall HamiltonG5

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
    71234
  • Event Risk Class
    Class 2
  • Event Number
    Z-2057-2015
  • Event Initiated Date
    2015-03-24
  • Event Date Posted
    2015-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136935
  • 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
    Customer reports that the ventilator display can freeze. ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
  • Action
    *** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.

Device

Device Recall HamiltonG5
  • Model / Serial
    Software version 2.20 and 2.41,
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Hamilton-G5 Ventilators with software versions V2.40/2.41 || Catalog numbers for G5: 159001 and 159002. Software: 159700.. || Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
  • 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