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
    35779
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-01
  • 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 recently detected a leak in the water circuit of an hcu 40 during the final quality inspection. the investigation revealed that the leakage was caused by a damaged sealant in the water circuit. the damage occurred during device assembly and it cannot be ruled out with absolute certainty that hcu 40s in the field equipped with the same type of sealant could exhibit this failure too. the hcu 40 with the serial number 90440265 could potentially exhibit a leak in the water circuit. in case of water leakage a short circuit of an electrical component and device shut down are the potential consequences.

Device

HEATER-COOLER UNIT HCU 40
  • Model / Serial
    Model Catalog: 70105.4054 (200-240V) (Lot serial: 90440265)
  • 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