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
    78789
  • Event Risk Class
    II
  • Event Initiated Date
    2009-09-11
  • 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
    1)doppler signals may be truncated and peak gradients to be potentially obscured may result in the underestimation of peak velocity and a disease process 2)user records of heart be recorded using calipers on the ecg the heart rate value does not get reset during a new patient registration and calculations are based on the previous patient's results. 3)when a user searches for data the search result is for the patient in the study browser new study results are saved under patient the study brower is focused on. 4)when new patient is registered with no new parameters image from the last patient is appearing in the text for the new patient could result in misdiagnosis.

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