Events

Recall of DASH 4000 PATIENT MONITOR

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
    150219
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-19
  • 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
    The dash monitor may exhibit an unexpected loss of custom automatic nbp measurement cycling. when the custom automatic nbp measurement cycling turns off the auto message is no longer displayed in the nbp parameter window at the patient bedside monitor. the timestamp of the last nbp will remain displayed and not reset if no npb monitoring has taken place after 2 hours in adult icu mode 15 minutes in the operating room mode or 12 hours in neuonatal-icu mode.

Device

DASH 4000 PATIENT MONITOR
  • Model / Serial
    Model Catalog: DASH4-XXXX-XXXX-XXXX (Lot serial: n/a); Model Catalog: DASH5-XXXX-XXXX-XXXX (Lot serial: n/a); Model Catalog: DASH3-XXXX-XXXX-XXXX (Lot serial: n/a)
  • Product Description
    DASH 4000 PATIENT MONITOR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)