Events

Recall of ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS CANADA LIMITED - 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
    106908
  • Event Risk Class
    III
  • Event Initiated Date
    2011-01-17
  • 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
    This letter is to notify you that we have determined that there is an error in the estimation of mean pressure gradient in the cardiac measurement package available on all versions of acuson x300 ultrasound system.

Device

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC