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
    58014
  • Event Risk Class
    Class 2
  • Event Number
    Z-1928-2011
  • Event Initiated Date
    2011-02-16
  • Event Date Posted
    2011-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97973
  • 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
    Facility Use Continuous Ventilator - Product Code CBK
  • Reason
    The adaptive volume/pressure regulation can be automatically and permanently reduced to peep + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator.
  • Action
    A Medical device Safety Alert and Corrective Action along with a cover letter, was sent to all locations on February 16, 2011. The letter identified the affected product along with the reason for recall. The letter states that operators deactivate the "high tidal volume" alarm as described in appendix K.4 of the operator's manual until the ventilator is upgraded with a corrected software. Distributors will upgrade the affected devices with the corrected software as soon as possible. Questions can be directed to 800-426-6331, ext 215.

Device

Device Recall HamiltonG5 Ventilator
  • Model / Serial
    Software version V2.00x and Neonatal Option or V2.01x and Neonatal software
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MA, FL, GA, NC, MI, NC, MO, TX, and WV.
  • Product Description
    Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001; || Neonatal Software catalog number: 159700; Neonatal Option catalog number: 159187. Hamilton Medical || Intended for use in the hospital and institutional environment where healthcare professionals provide patient care.
  • 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