Events

Recall of VITREA ADVANCED SOFTWARE DVD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TOSHIBA CANADA MEDICAL SYSTEMS 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
    37033
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-28
  • 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
    Field correction based on a product labelling deficiency. potential user confusion when viewing a brain perfusion scan on vitrea ct brain perfusion 2d when the scan was performed using a wide coverage shuttle acquisition technique. user confusion may result in patient treatment delays misdiagnosis or mistreatment.

Device

VITREA ADVANCED SOFTWARE DVD
  • Model / Serial
    Model Catalog: VPMC-12393 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12252 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12324 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12395 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12508 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12190 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12253 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12325 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12396 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12509 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12193 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12254 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12506 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12189 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12322 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12021 (Lot serial: VERSION 5
  • Product Description
    VITREA ADVANCED SOFTWARE DVD
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

TOSHIBA CANADA MEDICAL SYSTEMS LIMITED
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    HC