Events

Recall of ALENTI LIFT HYGIENE CHAIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ARJO CANADA 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
    107504
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-03
  • 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
    To further reduce the number of incidents associated with the alenti chair arjohuntleigh would like to re-iterate the important safety information. previous field safety correction actions reiterated the importance of following the instructions for use provided and included the introduction of a supplementary wall chart in the 2007 action. arjohuntleigh has revised the supplementary wall chart in april 2013. the changes include: 1. the correct instruction to not activate the alenti brake after the patient is removed from the bath tub. 2. the correct instruction to dry the patient inside the bath tub.

Device

ALENTI LIFT HYGIENE CHAIR
  • Model / Serial
    Model Catalog: CDB8153-01 (Lot serial: NA); Model Catalog: CDB8003-01 (Lot serial: NA); Model Catalog: CDB8053-01 (Lot serial: NA); Model Catalog: CDB8103-01 (Lot serial: NA)
  • Product Description
    Alenti Lift & Hygiene Chair
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

ARJO CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC