Events

Recall of CARDIOHELP-I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    132984
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-21
  • 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
    Software update to address 1) unexpected shutdown and device restart of the touchscreen resulting in settings returning to those stored in the clinic configuration of the device and loss of manual settings and 2) the possibility that electromagnetic interference due to electric current fluctuations may cause pressure values on the display to freeze.

Device

CARDIOHELP-I
  • Model / Serial
    Model Catalog: 70104.8012 (Lot serial: ALL S/N UP TO 90410628); Model Catalog: 70104.8012 (Lot serial: EXCEPT 90410622)
  • Product Description
    CARDIOHELP-I
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC