Events

Recall of INNOVA E4 WASHER - DISINFECTOR

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

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
    16777
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-16
  • 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
    A hospital contacted scican on march 10 2016 to report difficulties with one of their e4-wd washer-disinfectors. the hospital's biomedical technician reported that he identified the upper water flap of one channel being stuck in the closed position. according to the hospital's biomedical technician a screw securing the water flap was suspected to be responsible for this issue. that specific screw was apparently loose and deflected the stainless steel insert spacer from its normal position causing it to miss the water flap which consequently remained closed. as the water flap was stuck in the closed position it did not allow the proper circulation of water and chemicals in the upper scope. the scopes located in that specific location were not reprocessed correctly. the biomedical technician has confirmed that this water flap was opening correctly until march 9th 2016.

Device

INNOVA E4 WASHER - DISINFECTOR
  • Model / Serial
    Model Catalog: E4-WD (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    INNOVA E4 WASHER-DISINFECTOR
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Scican Ltd
  • Source
    HC