Events

Recall of transcutaneous pCO2 electrodes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer 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
    60153
  • Event Risk Class
    Class 2
  • Event Number
    Z-0341-2012
  • Event Date Posted
    2011-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104616
  • 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
    Monitor, carbon-dioxide, cutaneous - Product Code LKD
  • Reason
    Transcutaneous pco2-electrodes were wrongly coded as: po2 electrode on the hardware plug for the firm's tcm series monitors. this causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
  • Action
    Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.

Device

transcutaneous pCO2 electrodes
  • Model / Serial
    Part Number: 945-655, Lot Code: DP-06
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.
  • Product Description
    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. || Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA