Events

Recall of QUICKIE MANUAL WHEELCHAIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUNRISE MEDICAL 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
    80733
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-04
  • 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
    Sunrise medical (us) llc has observed failure of the original backrest bracket (2009-2013) which can fatigue over the lifetime of the product. when this occurs there is a possibility of the bracket fracturing causing the backrest to detach from the chair frame. the root cause was found to be insufficient material in a high stress area. under certain loading conditions these high stresses can lead to material fatigue and ultimately failure of the bracket.

Device

QUICKIE MANUAL WHEELCHAIR
  • Model / Serial
    Model Catalog: EIR4 (Lot serial: > 10 contact manufacturer)
  • Product Description
    Quickie Q7 Manual Wheelchair with Backrest Brackets
  • Manufacturer
    SUNRISE MEDICAL CANADA INC.

Manufacturer

SUNRISE MEDICAL CANADA INC.