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
    29222
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-13
  • 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
    The ground wire of the supply transformer frame on a getinge 9100-series washer disinfector exhibited signs of high resistance on one installation in australia. result from investigation determined a poor connection due to varnished terminal mounting rails along the grounding path. this in combination with the current design of potential ground distribution on the transformer may give high eddy currents.

Device

WASHER/DISINFECTOR
  • Model / Serial
    Model Catalog: 9128 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 9120 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 9027 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 9125 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Description
    MEDICAL WASHER DISINFECTOR
  • Manufacturer
    GETINGE CANADA LIMITED

Manufacturer

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