Events

Recall of EMBRYOSCOPE ES-D

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VITROLIFE A/S.

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
    74020
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-15
  • 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
    When cleaning or disinfecting parts of the embryoscope time-lapse incubator the metal clips which are attached to the embryo chamber and support the transparent plate positioned over the culture dish holder may come loose.

Device

EMBRYOSCOPE ES-D
  • Model / Serial
    Model Catalog: ESD20000-JAP (Lot serial: N/A)
  • Product Description
    EMBRYOSCOPE ES-D
  • Manufacturer
    VITROLIFE A/S

Manufacturer

VITROLIFE A/S
  • Manufacturer Address
    VIBY J
  • Manufacturer Parent Company (2017)
    Vitrolife AB
  • Source
    HC