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
    62189
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-07
  • 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 scanning with the 18l6 hd transducer on the acuson helxt evolution with touch control the ultrasound system may display a triple image or an image with a dark band. for the triple image issue the system repeats one-third of the aperture but does not display the full field of view. this issue occurs intermittently when connecting the 18l6 hd transducer to the ultrasound system or when selecting the touch screen control to activate the transducer.

Device

ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 10441730 (Lot serial: ALL); Model Catalog: 10441701 (Lot serial: ALL); Model Catalog: 10041461 (Lot serial: ALL)
  • Product Description
    ACUSON S3000;ACUSON S1000;ACUSON S2000
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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