Events

Recall of MPS 2 CONSOLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by QUEST MEDICAL 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
    Recall
  • Event ID
    19497
  • Event Risk Class
    III
  • Event Initiated Date
    2017-05-26
  • 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
    Using the external pressure transducer to monitor either antegrade or retrograde pressure may result in inaccurate pressure readings displayed on the mps 2 console when only one transducer is connected to the console.

Device

MPS 2 CONSOLE
  • Model / Serial
    Model Catalog: 5201260 (Lot serial: All MPS 2 Consoles)
  • Product Description
    Myocardial Protection System (MPS) 2 Console
  • Manufacturer
    QUEST MEDICAL INC.

Manufacturer

QUEST MEDICAL INC.