Events

Recall of INNOVA E5 CMS

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
    94855
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-07
  • 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
    This recall has been initiated by the manufacturer for their innova units in order to send updated operator's manuals to the end users. there is no safety issue related to this recall and the units can continue to be used.

Device

INNOVA E5 CMS
  • Model / Serial
    Model Catalog: E5-CMS (Lot serial: >10 numbers contact mfg); Model Catalog: E4-WD (Lot serial: >10 numbers contact mfg); Model Catalog: E5CMS-DH (Lot serial: >10 numbers contact mfg); Model Catalog: ESCMS-DC-EFF (Lot serial: >10 numbers contact mfg); Model Catalog: 50000.10 (Lot serial: 7514407); Model Catalog: 50200.01 (Lot serial: 5800301); Model Catalog: 50200.02 (Lot serial: 5490700); Model Catalog: 50200.01 (Lot serial: 5490700); Model Catalog: 50200.02 (Lot serial: 5220999); Model Catalog: 50200.01 (Lot serial: 5220999); Model Catalog: E2-WD** (Lot serial: >10 numbers contact mfg); Model Catalog: E2-WD (Lot serial: >10 numbers contact mfg); Model Catalog: 50200.02 (Lot serial: 5800301); Model Catalog: 50200.02 (Lot serial: 4871098); Model Catalog: 50200.01 (Lot serial: 4871098); Model Catalog: E3-WD (Lot serial: >10 numbers contact mfg); Model Catalog: E3-WD-R (Lot serial: >10 numbers contact mfg); Model Catalog: 50600.10 (Lot serial: >10 numbers contact mfg); Model Catalog: 50600.10*** (Lot serial: >1
  • Product Description
    INNOVA E5 CMS WASHER-DISINFECTORS;INNOVA E4 WASHER-DISINFECTORS;INNOVA 700 WASHER-DISINFECTORS;INNOVA M4/1080* WASHER-DISINFECTORS;INNOVA E2 WASHER-DISINFECTORS;INNOVA E3 WASHER-DISINFECTORS;INNOVA E3;INNOVA M5 WASHER-DISINFECTORS;INNOVA M3 WASHER-DISINFE
  • Manufacturer
    SCICAN LTD.

Manufacturer

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