Events

Recall of LIGHT IMAGE O-SPOTS

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

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
    89276
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-28
  • 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
    Recall is due to the possibility that the dispensor is mislabeled as "soft n' stretchy light image s-spots (ref# 677)". the risk exists that any confusion could cause concern and the need to re-image if it was to be used on a patient to mark a scar instead of a mole.

Device

LIGHT IMAGE O-SPOTS
  • Model / Serial
    Model Catalog: 252 (Lot serial: Lot#: 252.04261301)
  • Product Description
    Light Image O-Spots
  • Manufacturer
    BEEKLEY CORPORATION

Manufacturer

BEEKLEY CORPORATION