Events

Recall of HEATER-COOLER UNIT HCU 40

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
    99371
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-13
  • 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
    Maquet cardiopulmonary developed and validated new and revised cleaning and disinfection procedures for hcu 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all hcu 40 systems in the field. the implementation of the new procedures for installed hcu 40 units requires an update by authorized maquet service personnel. customers will be notified and technicians will be dispatched to perform the updates and distribute new ifus.

Device

HEATER-COOLER UNIT HCU 40
  • Model / Serial
    Model Catalog: 70105.4054 (200-240V) (Lot serial: > 10 numbers contact mfg); Model Catalog: 70105.4917 (110-120V) (Lot serial: > 10 numbers contact mfg)
  • Product Description
    HEATER-COOLER UNIT HCU 40
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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