Recall of ECG/ESIS MODULE *116597

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS MEDICAL PRODUCTS LTD.

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
    27122
  • Event Risk Class
    II
  • Event Initiated Date
    1996-03-28
  • Event Country
  • 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

Device

  • Model / Serial
    Model Catalog: (Lot serial: model 90427); Model Catalog: (Lot serial: model 90418); Model Catalog: (Lot serial: models 90332 90334 90335); Model Catalog: (Lot serial: models 90336 90338); Model Catalog: (Lot serial: models 90407 90408); Model Catalog: (Lot serial: model 90432); Model Catalog: (Lot serial: model 90425); Model Catalog: (Lot serial: model 90428)
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC