Events

Recall of DUAL TEMPERATURE CABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS HEALTHCARE (CANADA) 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
    143875
  • Event Risk Class
    II
  • Event Initiated Date
    2008-08-18
  • 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
    Cable failing to meet its specification.

Device

DUAL TEMPERATURE CABLE
  • Model / Serial
    Model Catalog: 700-0031-00 (Lot serial: OSC 04/07); Model Catalog: 700-0031-00 (Lot serial: OSC 02/07); Model Catalog: 700-0031-00 (Lot serial: OSC 01/07); Model Catalog: 700-0031-00 (Lot serial: OSC 06/07); Model Catalog: 700-0031-00 (Lot serial: OSC 07/07); Model Catalog: 700-0031-00 (Lot serial: OSC 03/07)
  • Product Description
    DUAL TEMPERATURE CABLE
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    HC