Events

Recall of SAFE 3000 AUTOFLUORESCENCE VIDEO PROCESSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTAX CANADA 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
    14648
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-25
  • 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
    The manufacturer is conducting a field corrective action to update the sub cpu firmware of safe-3000 to version 1.30 by replacement of the main pcb after it was determined that older safe 3000 processors may not work properly with 30/70k endoscopes.

Device

SAFE 3000 AUTOFLUORESCENCE VIDEO PROCESSOR
  • Model / Serial
    Model Catalog: SAFE 3000 (Lot serial: UA010011); Model Catalog: SAFE 3000 (Lot serial: UA010012); Model Catalog: SAFE 3000 (Lot serial: UA010013); Model Catalog: SAFE 3000 (Lot serial: UA010014)
  • Product Description
    SAFE-3000 AUTOFLUORESCENCE VIDEO PROCESSOR
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    HC