Events

Recall of ENCORE STANDING AID

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
    55894
  • Event Risk Class
    I
  • Event Initiated Date
    2012-05-24
  • 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
    Arjohuntleigh has been made aware of a serious incident. during exercise a standing and raising aid was used to support a patient to stand. the knee pad had been removed. however the support bracket holding the proactive knee pad support had not been removed as described in the instructions for use manual. this results in a vertical square section end of the metal support bracket becoming exposed and patients may fall onto the metal bracket causing severe trauma. this accident could have been avoided if the support bracket assembly had been removed with the proactive knee pad support. arjohuntleigh would like to remind users that the entire knee pad and support bracket assembly must be removed when required to do so for exercise.

Device

ENCORE STANDING AID
  • Model / Serial
    Model Catalog: KKB5040-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5042-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5022-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5020-21US (Lot serial: >100 numbers contact mfg); Model Catalog: HEP1001-US (Lot serial: >100 numbers contact mfg); Model Catalog: HEP0001-US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5060-23US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5060-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5080-21US (Lot serial: >100 numbers contact mfg); Model Catalog: KKB5080-23US (Lot serial: >100 numbers contact mfg)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    ENCORE STANDING AID
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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