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
    36658
  • Event Risk Class
    III
  • Event Initiated Date
    2009-10-09
  • 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
    When using the ultrasound cardiac workflow under specific depths and scales the affected systems create a band of lost signals in a horizontal orientation which could result in the underestimation of the peak velocity and a disease process.

Device

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION
  • Model / Serial
    Model Catalog: 10348531 (Lot serial: 313273); Model Catalog: 10348531 (Lot serial: 313171)
  • Product Description
    ACUSON X300
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

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