Events

Recall of TRU-LINK PRE-WIRED DIN SAFETY NEONATAL ECG ELECTRODE

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
    152439
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-27
  • 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
    Specific lot codes of trulink pre-wired neonate ecg electrodes may have a loose wire that could result in intermittent connections and poor signal quality. this could cause a loss in ecg patient monitoring.

Device

TRU-LINK PRE-WIRED DIN SAFETY NEONATAL ECG ELECTRODE
  • Model / Serial
    Model Catalog: 685-0037-00 (Lot serial: 0904014 THROUGH 1007064)
  • Product Description
    TRULINK PRE-WIRED NEONATE ECG ELECTRODE
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

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