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
    46106
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-20
  • 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
    The acuson sc2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. the system recalls the case sensitivity even if the original study has been removed from the hard drive. if these differences are not corrected at the time of registration the system does not capture images or clips.

Device

ACUSON SC2000 ULTRASOUND SYSTEM - MAINFRAME
  • Model / Serial
    Model Catalog: 10433816 (Lot serial: 401896); Model Catalog: 10433816 (Lot serial: 401876); Model Catalog: 10433816 (Lot serial: 401794 400111); Model Catalog: 10433816 (Lot serial: 401499); Model Catalog: 10433816 (Lot serial: 400319 401223); Model Catalog: 10433816 (Lot serial: 401822)
  • 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