Events

Recall of ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT

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
    68316
  • 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
    There is an intermittent series of events in which a print or store event failure may cause the following to occur: a)the last image of a patient study can be stored with the next new patient study performed. b)if the first patient's last image had measurement results will appear on the next patient's image. c) when a distance ratio or area ratio measurement is performed with l testis mass 2 measurement label it appears in the report as r testis mass 2 in english only and d) more than 4 measurements of the same label are performed will not apear on-screen or printed report.

Device

ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 10041461 (Lot serial: 200252); Model Catalog: 10041461 (Lot serial: 200995); Model Catalog: 10041461 (Lot serial: 200979); Model Catalog: 10041461 (Lot serial: 200926); Model Catalog: 10041461 (Lot serial: 200334); Model Catalog: 10041461 (Lot serial: 200288)
  • Product Description
    ACUSON S2000
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

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