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
    106164
  • Event Risk Class
    III
  • Event Initiated Date
    2013-01-18
  • 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
    Ge healthcare became aware of the following issues affecting dash 3000/4000/5000 patient monitors and dash port 2. dash 3000/4000/5000 patient monitors: 1. dash stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* 2. dash displays distorted ecg waveforms in combination monitoring mode 3. dash incorrectly becomes time master on the unity network 4. dash date reverts to 1993 dash port 2: 5. dash port 2 stops communicating on the unity network resulting in loss of monitoring at the carescapet cic pro central station* *despite communication loss the dash 3000/4000/5000 will continue to provide bedside monitoring including alarms and event storage.

Device

DASH 4000 PATIENT MONITOR
  • Model / Serial
    Model Catalog: DASH4-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: DASH5-XXXX-XXXX-XXXX (Lot serial: >10 lot numbers contact mfg); Model Catalog: 2041850-002 (Lot serial: >10 lot numbers contact mfg); Model Catalog: DASH3-XXXX-XXXX-XXXX (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    DASH 4000 PATIENT MONITOR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)