Events

Recall of GETINGE STEAM STERILIZER

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
    101141
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-26
  • 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 has revised the preventive maintenance requirements for the model 233 steam sterilizer to included a more detailed routine inspection of the door system adjustments. if the door is not adjusted properly sterilization cycles may not start may abort or the the door may unseal while under pressure.

Device

GETINGE STEAM STERILIZER
  • Model / Serial
    Model Catalog: 233 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    Castle Model 233 Steam Sterilizer
  • Manufacturer
    GETINGE CANADA LIMITED

Manufacturer

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