Events

Recall of ACUSON SC2000 ULTRASOUND SYSTEM - MAINFRAME

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
    91308
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-31
  • 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
    Siemens is notifying users of a potential issue with the acuson sc2000 ultrasound system with software versions vb10a vb10b vb10d and vb10e. the 3d esie pisa volume analysis application quantifies valvular regurgitation. while imaging with the z6ms volume transesophageal echocardiography transducer this application may underestimate the eroa (effective regurgitant orifice area) in comparison to the same patient results obtained with the 4z1c volume transthoracic echocardiography transducer.

Device

ACUSON SC2000 ULTRASOUND SYSTEM - MAINFRAME
  • Model / Serial
    Model Catalog: 10433816 (Lot serial: ALL)
  • Product Description
    ACUSON SC2000 ULTRASOUND SYSTEM- MAINFRAME
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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