Events

Recall of Device Recall Compumedics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Compumedics Usa, Ltd.

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
    31197
  • Event Risk Class
    Class 2
  • Event Number
    Z-0652-05
  • Event Initiated Date
    2005-02-24
  • Event Date Posted
    2005-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37350
  • 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
    Full-Montage Standard Electroencephalograph - Product Code GWQ
  • Reason
    Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
  • Action
    The firm initiated the recall on February 24, 2005 via letter with return response post card.

Device

Device Recall Compumedics
  • Model / Serial
    All codes
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide and to the following foreign countries: Australia, Canada, Greece, Hong Kong, Hungary, India, Iran, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pillippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
  • Product Description
    Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier.
  • Manufacturer
    Compumedics Usa, Ltd

Manufacturer

Compumedics Usa, Ltd
  • Manufacturer Address
    Compumedics Usa, Ltd, 7850 Paseo Del Norte, El Paso TX 79912
  • Source
    USFDA