Events

Recall of WASHER/DISINFECTOR

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

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
    22051
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-15
  • 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
    Getinge received two complaints that sediment residuals were found in the manifold of getinge 46 series washer /disinfectors with the drying option and pacs 300 controls. investigation revealed that there was insufficient water flow through the manifold which allowed air pockets to occur.

Device

WASHER/DISINFECTOR
  • Model / Serial
    Model Catalog: 46-5 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 46-4 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 46-2 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    WASHER/DISINFECTOR
  • Manufacturer
    GETINGE CANADA LIMITED

Manufacturer

GETINGE CANADA LIMITED
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC