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
    21231
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-06
  • 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
    Stryker medical has identified that on some units of the device there is a lack of a water temperature display while the unit is in auto mode. while in auto mode only the patient temperature is displayed along with the set point. the water display will be blank during auto mode. if the user wants to see the water temperature displayed and switches out of auto mode to manual mode then back to auto mode the therapy will be reset and may potentially cause patients to reach the set point earlier.

Device

MEDI-THERM III
  • Model / Serial
    Model Catalog: MTA7900 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    Medi-Therm Hyper/Hyperthermia Machine
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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