Events

Recall of ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    51819
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-30
  • 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
    Use of the software tool virtual touch tissue imaging quantification (vtiq) on the acuson s2000 and acuson s3000 systems has a potential measurement error. specifically the color mapping is misaligned with the b-mode image underneath. what this results in for the user is a difference between the color mapping and the shear wave velocity readout. the velocity result in m/s does not correspond with the velocity color scale. when repositioning the vtiq region of interest from the original location to a new one the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.

Device

ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 10441730 (Lot serial: 210225); Model Catalog: 10441730 (Lot serial: 210620); Model Catalog: 10441730 (Lot serial: 210793); Model Catalog: 10441730 (Lot serial: 211178); Model Catalog: 10441730 (Lot serial: 210144); Model Catalog: 10041461 (Lot serial: 210085); Model Catalog: 10041461 (Lot serial: 211432); Model Catalog: 10041461 (Lot serial: 211445); Model Catalog: 10041461 (Lot serial: 206341)
  • Product Description
    ACUSON S3000
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC