Events

Recall of Device Recall Hamilton

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
    35592
  • Event Risk Class
    Class 2
  • Event Number
    Z-1249-06
  • Event Initiated Date
    2006-05-24
  • Event Date Posted
    2006-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46437
  • 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 - Product Code CBK
  • Reason
    Alarm failure-following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
  • Action
    On May 24, 2006 the manufacturer initiated this recall. The Recalling establishment/US Initial Importer/Distributor-received the manufacturer''s notice on May 31, 2006 and initiated their recall on June 1, 2006. The US distributor has issued a Medical Device Field Correction.

Device

Device Recall Hamilton
  • Model / Serial
    Serial Numbers 2975 to 5360
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Manufacturer Address
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89520-3008
  • Source
    USFDA