Events

Recall of FLOPOINT UROFLOW SYSTEM - COMMUNICATION CRADLE

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
    43294
  • Event Risk Class
    III
  • Event Initiated Date
    2010-09-28
  • 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
    Verathon's scanpoint communication cradles that were incorrectly programmed with alpha numeric serial #s during manufacturing thus the cradles may not be able to communicate with scanpoint online tool through quickprint interface for exam storage and/or calibration.

Device

FLOPOINT UROFLOW SYSTEM - COMMUNICATION CRADLE
  • Model / Serial
    Model Catalog: 0570-0168 (Lot serial: CC012000-CC012084)
  • Product Description
    ScanPoint Communication Cradle
  • Manufacturer
    VERATHON INC.

Manufacturer

VERATHON INC.