Events

Recall of JOSTRA HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT VARIOUS VOLTAGES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    27118
  • Event Risk Class
    II
  • Event Initiated Date
    2006-11-28
  • 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
    During the cleaning cycle there is a possibility for the device to overheat. this occurs when the cycle is run and the water level is too low.

Device

JOSTRA HEATER-COOLER UNIT 30 SYSTEM - MAIN UNIT VARIOUS VOLTAGES
  • Model / Serial
    Model Catalog: 00939001 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 00939001 (Lot serial: >10 SERIAL NUMBERS)
  • Product Description
    JOSTRA HEATER-COOLER UNIT 30 SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC