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
    23225
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-02
  • 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
    It has been found that the sara 3000 sara plus minstrel and tenor devices have experienced problems with the electrical functions related to the printed circuit board (pcb) losing the safe working load (swl) settings resulting in the inconvenience of the device usage. arjohuntleigh has decided to perform a pcb software upgrade to eliminate the detected problem.

Device

ARJO TENOR MOBILE LIFT
  • Model / Serial
    Model Catalog: KHAXXX (Lot serial: 03.08.2016 - 31.08.2017); Model Catalog: KHAXXX (Lot serial: manufactured between); Model Catalog: HEAXXXX (Lot serial: 31.05.2016 - 31.08.2017); Model Catalog: HEAXXXX (Lot serial: manufactured between); Model Catalog: HEPXXXX (Lot serial: 12.10.2016 - 31.08.2017); Model Catalog: HMAXXX (Lot serial: manufactured between); Model Catalog: HMAXXX (Lot serial: 12.09.2016 - 31.08.2017); Model Catalog: HEPXXXX (Lot serial: manufactured between)
  • Product Description
    TENOR MOBILE LIFT;SARA 3000 PATIENT LIFT;SARA PLUS STANDING AID;MINSTREL PATIENT LIFT
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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