Events

Recall of MERGE ORTHOCASE

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

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
    50713
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-29
  • 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 using the perpendicular line tool there is an option to "snap" the lines together which prevents the perpendicular lines from extending past the straight/base line. while the system default is set to snap the lines together the actual "snap" function may not occur until the plan is saved at which time the line end point within 20 pixels of the base line will adjust its location to snap perfectly to the base line. this may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.

Device

MERGE ORTHOCASE
  • Model / Serial
    Model Catalog: MERGE ORTHOCASE (Lot serial: >10 CONTACT MANUFACTURER)
  • Product Description
    MERGE ORTHOCASE
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED