Events

Recall of Teledyne Analytical Instruments

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teledyne Analytical Instruments.

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
    27593
  • Event Risk Class
    Class 2
  • Event Number
    Z-0145-04
  • Event Initiated Date
    2003-10-27
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30153
  • 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, Oxygen, Gaseous-Phase - Product Code CCL
  • Reason
    Potential failure to display the battery low light to the end-user.
  • Action
    All affected customers will be notified by letter on 10/27/2003. All units returned will be reworked and 100% retested prior to shipment.

Device

Teledyne Analytical Instruments
  • Model / Serial
    Model AX300, Model MX300
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, CA, UT, AZ and MO. New Zealand, Australia, Canada and the United Kingdom
  • Product Description
    Portable Oxygen Analyzer
  • Manufacturer
    Teledyne Analytical Instruments

Manufacturer

Teledyne Analytical Instruments
  • Manufacturer Address
    Teledyne Analytical Instruments, 16830 Chestnut St, Rowland Heights CA 91748-1017
  • Source
    USFDA