Events

Recall of MEDI-THERM III

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    25498
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-11
  • 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
    Due to an assembly error the (protective) adhesive tabs were not removed during the application of the panel digital control to the head assembly of the units. this may result in insufficient conductivity of the panel's emi ground layer to the chassis/system ground potentially causing performance anomalies from electromagnetic interference. prior to device assembly these conductive pads are covered by protective white tabs to preserve the integrity of the conductive epoxy. these white tabs should have been removed prior to installation of the panel to the head assembly.

Device

MEDI-THERM III
  • Model / Serial
    Model Catalog: MTA7900 (Lot serial: S/N: D21023)
  • Product Description
    MEDI-THERM III
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC