Events

Recall of ALEX/SEDEO SEATING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUNRISE MEDICAL HCM 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
    154226
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-10
  • 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
    Potential issue was discovered with the "compact lights" supplied on the "alex" power chairs sold in canada with this option. the supplied incandescent light bulbs might cause overheating and as a result parts of the compact lights unit could melt or in extreme situations ignite. handicare bv has decided as a precautionary measure to replace the lights in the compact lights unit with new led lights.

Device

ALEX/SEDEO SEATING SYSTEM
  • Model / Serial
    Model Catalog: ALEX PWC (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    ALEX POWER WHEELCHAIRS
  • Manufacturer
    SUNRISE MEDICAL HCM INC.

Manufacturer

SUNRISE MEDICAL HCM INC.