According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS HEALTHCARE 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
  • Event ID
  • Event Risk Class
  • Event Initiated Date
  • Event Country
  • Event Source
  • 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
    There is an anomaly in the ecg software that fails to detect low heart rates in the range of 12 to 15 bpm under some unusual conditions. only one report has been received regarding this anomaly.


  • Model / Serial
    Model Catalog: 90470 (Lot serial: CONTACT); Model Catalog: 90470 (Lot serial: >1000 NUMBERS); Model Catalog: 90470 (Lot serial: MANUFACTURER); Model Catalog: 90344 (Lot serial: MANUFACTURER); Model Catalog: 90496 (Lot serial: CONTACT); Model Catalog: 90478 (Lot serial: MANUFACTURER); Model Catalog: 90478 (Lot serial: CONTACT); Model Catalog: 90478 (Lot serial: >100 NUMBERS); Model Catalog: 90348 (Lot serial: MANUFACTURER); Model Catalog: 90346 (Lot serial: MANUFACTURER); Model Catalog: 90496 (Lot serial: >1000 NUMBERS); Model Catalog: 90342 (Lot serial: MANUFACTURER); Model Catalog: 90348 (Lot serial: CONTACT); Model Catalog: 90346 (Lot serial: CONTACT); Model Catalog: 90344 (Lot serial: CONTACT); Model Catalog: 90342 (Lot serial: CONTACT); Model Catalog: 90348 (Lot serial: >10 NUMBERS); Model Catalog: 90346 (Lot serial: >10 NUMBERS); Model Catalog: 90344 (Lot serial: >10 NUMBERS); Model Catalog: 90342 (Lot serial: >10 NUMBERS); Model Catalog: 90496 (Lot serial: MANUFACTURER)
  • Product Description
  • Manufacturer


  • Manufacturer Address
  • Source