Events

Recall of PATIENT DATA MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    55200
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-30
  • 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
    When certain monitoring systems using a patient data module are configured for auto-mode non-invasive blood pressure measurements it is possible that the auto mode measurements may stop automatically cycling. the problem may not be apparent to the caregiver because the last measurement remains on the screen. the caregiver can however view the timestamp of the last auto mode determination to see that periodic cycling has stopped.

Device

PATIENT DATA MODULE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)