Events

Recall of Device Recall Continuous 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
    77617
  • Event Risk Class
    Class 2
  • Event Number
    Z-0335-2018
  • Event Initiated Date
    2017-06-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156855
  • 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
    Cuff, tracheal tube, inflatable - Product Code BSK
  • Reason
    Issue related to the performance of the motor in recalled product. during use, motor may cease to function.
  • Action
    Hamilton Medical sent a Recall Notice dated June 20, 2017, notifying them of the device correction. Consignees were informed that a Hamilton Representative would be in contact with them regarding the return of any devices. For further questions, please call (775) 858-3200.

Device

Device Recall Continuous Ventilator
  • Model / Serial
    Serial No. 1000 thru 2090; P/N 951001
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to IL and TX.
  • Product Description
    Intellicuff Standalone (PN 951001) || Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
  • 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