Events

Recall of Device Recall Gas analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nihon Kohden America 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
    28025
  • Event Risk Class
    Class 2
  • Event Number
    Z-0506-04
  • Event Initiated Date
    2003-12-05
  • Event Date Posted
    2004-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31060
  • 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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
  • Reason
    Manufacturing error results in screw affecting electromagnetic interferences. also metal lid is not tight enough.
  • Action
    Consignees were notified on 12/5/03. All have received return authorizations.

Device

Device Recall Gas analyzer
  • Model / Serial
    Serial numbers 00001 to 00020, 00022, 00023, 00024, 00029.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, OK, NV
  • Product Description
    AG-920RA Multi-gas unit analyzer
  • Manufacturer
    Nihon Kohden America Inc

Manufacturer

Nihon Kohden America Inc
  • Manufacturer Address
    Nihon Kohden America Inc, 90 Icon, Foothill Ranch CA 92610-3000
  • Source
    USFDA