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
    106283
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-27
  • 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 a possible synchronization error with software versions vb20 vb20a and vb21a which can cause a mismatch between the image and the depth scale. the code allows for imaging events to be sent while the system is in suspend mode. this is used when entering exam review from a live imaging state. the control panel has an error where it sends erroneous events. a control panel bug allows for erroneous control panel events to trigger a mismatch between region of cal (roc) and actual image geometry.

Device

ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT

Manufacturer

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