Events

Recall of ARJO TENOR MOBILE LIFT

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
    74502
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-15
  • 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
    During use with the tenor without scale unit the part# ten.018 bolt is subjected to mechanical forces which may lead to breakage due to the design of the connection between spreader bar and lifting arm jig. the current design of suspension of the tenor spreader bar is causing adverse bending tension on suspension bolt ten.018 during specific use situations such as the load mass of the patient is unevenly placed in the sling the caregiver attempts to move the lift by pushing or pulling the suspended patient body sling or spreader bar. this is revealed in long term use as metal fatigue and the formation of micro-cracks in the thread.

Device

ARJO TENOR MOBILE LIFT
  • Model / Serial
    Model Catalog: KHA1000-US (Lot serial: > 10 numbers contact mfg)
  • Product Description
    Tenor Mobile Patient Lifter (non-scale version)
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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