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
    147670
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-03
  • 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 products affected by this recall are the innova e4 washer-disinfectors manufactured by scican gmbh. this recall is being initiated as a result of a recent service of 4 units at one location which identified that the insert spacer on the lower loading rack of the trolley had come off 3 of the 4 units. this insert spacer is located on the trolley where flexible scopes are loaded. when this trolley is inserted into the unit this component slides a mechanism aside that blocks the flow of water and chemical when the trolley is not in place. without this component in place there is nothing to slide the mechanism aside and therefore no flow of chemical to reprocess the scope. while there have been no other reports of this nature it was imperative that all innova e4 units be inspected to ensure that the fitting is securely in place.

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