Events

Recall of SURESIGHT VISION SREENER SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WELCH ALLYN 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
    130075
  • Event Risk Class
    III
  • Event Initiated Date
    2015-08-19
  • 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
    During service suresight vision screeners were calibratedand the that the calibration activity performed may not have returned the device to working order. in its current state the device will most likely not be able to take a reading or it may be very difficult to get a reading. devices affected are limited to those serviced between july 17 2015 and aug 7 2015 at the welch allyn skaneateles falls location.

Device

SURESIGHT VISION SREENER SET
  • Model / Serial
    Model Catalog: 14016 (Lot serial: 200700407); Model Catalog: 14016 (Lot serial: 200700393); Model Catalog: 14016 (Lot serial: 200700405); Model Catalog: 14016 (Lot serial: 200800014); Model Catalog: 14016 (Lot serial: 200700495); Model Catalog: 14016 (Lot serial: 200700403)
  • Product Description
    WELCH ALLYN SURESIGHT VISION SCREENER
  • Manufacturer
    WELCH ALLYN INC.

Manufacturer

WELCH ALLYN INC.