Events

Recall of ARJO MAXI 500

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

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
    32376
  • Event Risk Class
    II
  • Event Initiated Date
    2008-10-02
  • 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
    Decrochement de la traverse. la cause initiale de cette defaillance est la contamination de la matiere premiere de l'arbre pivot qui retient la traverse.

Device

ARJO MAXI 500
  • Model / Serial
    Model Catalog: KM560108 (Lot serial: ENTRE KM56-10015 ET KM56-11074); Model Catalog: KM560104 (Lot serial: ENTRE KM56-10015 ET KM56-11074); Model Catalog: KM560101 (Lot serial: ENTRE KM56-10015 ET KM56-11074); Model Catalog: KM560184 (Lot serial: ENTRE KM56-10015 ET KM56-11074); Model Catalog: KM560188 (Lot serial: ENTRE KM56-10015 ET KM56-11074); Model Catalog: KM560181 (Lot serial: ENTRE KM56-10015 ET KM56-11074)
  • Product Description
    ARJO MAXI 500
  • Manufacturer
    ARJOHUNTLEIGH MAGOG

Manufacturer

ARJOHUNTLEIGH MAGOG
  • Manufacturer Address
    MAGOG
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC