Events

Recall of BLADDERSCAN BVI 9600 WITH AORTASCAN CONSOLE AND PROBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VERATHON INC..

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
    18395
  • Event Risk Class
    I
  • Event Initiated Date
    2015-11-09
  • 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
    Notification that use of medical device was not intended to include detection of abdominal aortic aneurysms(aaa).A negative result may underreport the actual diameter of a patient's abdominal aorta and may result in a false negative re. aaa detection.

Device

BLADDERSCAN BVI 9600 WITH AORTASCAN CONSOLE AND PROBE
  • Model / Serial
    Model Catalog: BVI 9600 SYSTEM (Lot serial: all - contact manufacturer); Model Catalog: AMI 9700 SYSTEM (Lot serial: all - contact manufacturer)
  • Product Classification
    Radiology Devices
  • Product Description
    BladderScan BVI 9600
  • Manufacturer
    VERATHON INC.

Manufacturer

VERATHON INC.