Events

Recall of VITREA2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANON MEDICAL SYSTEMS CANADA 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
    106136
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-18
  • 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
    Found during in-house testing - incorrect image orientation may occur when loading a study into the 3d viewer in vitreacore taking a 16-bit secondary capture snapshot and loading this in a dicom viewer. orientation markers displayed in a dicom viewer may be incorrect.

Device

VITREA2
  • Model / Serial
    Model Catalog: VPMC-12323 (Lot serial: Vitreacore 6.1); Model Catalog: VPMC-12193 (Lot serial: Vitreacore 6.2); Model Catalog: VPMC-12023 (Lot serial: Vitreacore 6.1); Model Catalog: VPMC-12323 (Lot serial: Vitreacore 6.0); Model Catalog: VPMC-11907 (Lot serial: Vitreacore 6.0); Model Catalog: VPMC-12023 (Lot serial: Vitreacore 6.0); Model Catalog: VPMC-13023 (Lot serial: Vitreacore 6.5); Model Catalog: VPMC-12327 (Lot serial: Vitreacore 6.5); Model Catalog: VPMC-12256 (Lot serial: Vitreacore 6.5); Model Catalog: VPMC-12511 (Lot serial: Vitreacore 6.5); Model Catalog: VPMC-12398 (Lot serial: Vitreacore 6.5); Model Catalog: VPMC-12193 (Lot serial: Vitreacore 6.5); Model Catalog: VPMC-13023 (Lot serial: Vitreacore 6.4); Model Catalog: VPMC-12327 (Lot serial: Vitreacore 6.4); Model Catalog: VPMC-12256 (Lot serial: Vitreacore 6.4); Model Catalog: VPMC-12511 (Lot serial: Vitreacore 6.4); Model Catalog: VPMC-12398 (Lot serial: Vitreacore 6.4); Model Catalog: VPMC-12193 (Lot serial: Vitreacore 6.4); Model Catalog:
  • Product Description
    VITREA2
  • Manufacturer
    CANON MEDICAL SYSTEMS CANADA LIMITED

Manufacturer

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