Events

Recall of MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM - MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS CALIFORNIA LLC.

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
    66207
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Certain types of electri-cord manufacturing company power cords used with medical devices may be defective as the power cords prongs may crack and fail at or inside the plug. the issue affects medical device ac power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("tall bridge" design). medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected.

Device

MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM - MONITOR
  • Model / Serial
    Model Catalog: U6590-00 (Lot serial: 1432); Model Catalog: 6590-00 (Lot serial: 1432); Model Catalog: U6590-00 (Lot serial: 1392); Model Catalog: 6590-00 (Lot serial: 1392); Model Catalog: U6590-00 (Lot serial: 1594); Model Catalog: 6590-00 (Lot serial: 1594); Model Catalog: 5758-00 (Lot serial: 5904); Model Catalog: 5758-00 (Lot serial: 4824); Model Catalog: 5758-00 (Lot serial: 5629); Model Catalog: 5758-00 (Lot serial: 4859); Model Catalog: 5758-00 (Lot serial: 4728); Model Catalog: 5758-00 (Lot serial: 4723); Model Catalog: 5758-00 (Lot serial: 6213); Model Catalog: 5758-00 (Lot serial: 5436); Model Catalog: U6590-00 (Lot serial: 1579); Model Catalog: 6590-00 (Lot serial: 1579); Model Catalog: U6590-00 (Lot serial: 2129); Model Catalog: 6590-00 (Lot serial: 2129); Model Catalog: U6590-00 (Lot serial: 1509); Model Catalog: 6590-00 (Lot serial: 1509); Model Catalog: U6590-00 (Lot serial: 1472); Model Catalog: 6590-00 (Lot serial: 1472); Model Catalog: U6590-00 (Lot serial: 1455); Model Catalog: 6590-00 (Lo
  • Product Description
    MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM
  • Manufacturer
    RESPIRONICS CALIFORNIA LLC

Manufacturer

RESPIRONICS CALIFORNIA LLC
  • Manufacturer Address
    CARLSBAD
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC