Events

Recall of FREEDOM EVO 200

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

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
    46393
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-27
  • 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
    There is a potential in some circumstances that the adjustable front panel door may unexpectantly fall down from an upright position and cause an injury to an operator.

Device

FREEDOM EVO 200
  • Model / Serial
    Model Catalog: COVER GLASS TOP: 30032215 (Lot serial: S/N 1109006938); Model Catalog: MCA96 BASE UNIT: 30020020 (Lot serial: S/N 1109006938); Model Catalog: COVER GLASS TOP: 30032217 (Lot serial: S/N 1011007461); Model Catalog: COVER GLASS TOP: 30032217 (Lot serial: S/N 1109006938); Model Catalog: COVER GLASS TOP: 30032215 (Lot serial: S/N 1011007461); Model Catalog: MCA96 BASE UNIT: 30020020 (Lot serial: S/N 1011007461)
  • Product Description
    FREEDOM EVO200 WITH ADJUSTABLE FRONT PANEL DOOR AND DUST COVER
  • Manufacturer
    TECAN SCHWEIZ AG

Manufacturer

TECAN SCHWEIZ AG
  • Manufacturer Address
    MANNEDORF
  • Manufacturer Parent Company (2017)
    Tecan Group AG
  • Source
    HC