Events

Recall of IVEA MODEL 500A

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANADIAN HOSPITAL SPECIALTIES LTD..

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
    79358
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-11
  • 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
    Rotational forces on the 16082 dowel pin during deploying or folding can cause the pin to slowly "screw" its way out of position. if the pin migrates enough to allow the brace to detach from the leg pivot fitting while a patient is ambulating with weight on the handles the product could slump to one side. this may cause the patient to stumble .

Device

IVEA MODEL 500A
  • Model / Serial
    Model Catalog: 500A (Lot serial: 100677); Model Catalog: 500A (Lot serial: 100650); Model Catalog: 500A (Lot serial: 100325); Model Catalog: 500A (Lot serial: 100463); Model Catalog: 500A (Lot serial: 100476); Model Catalog: 500A (Lot serial: 100647); Model Catalog: 500A (Lot serial: 100646); Model Catalog: 500A (Lot serial: 100645); Model Catalog: 500A (Lot serial: 100643); Model Catalog: 500A (Lot serial: 100642); Model Catalog: 500A (Lot serial: 100641); Model Catalog: 500A (Lot serial: 100640); Model Catalog: 500A (Lot serial: 100627); Model Catalog: 500A (Lot serial: 100626); Model Catalog: 500A (Lot serial: 100620); Model Catalog: 500A (Lot serial: 100615); Model Catalog: 500A (Lot serial: 100605); Model Catalog: 500A (Lot serial: 100602); Model Catalog: 500A (Lot serial: 100600); Model Catalog: 500A (Lot serial: 100598); Model Catalog: 500A (Lot serial: 100592); Model Catalog: 500A (Lot serial: 100574); Model Catalog: 500A (Lot serial: 100572); Model Catalog: 500A (Lot serial: 100571); Model Catalog:
  • Product Description
    IVEA MODEL 500A
  • Manufacturer
    CANADIAN HOSPITAL SPECIALTIES LTD.

Manufacturer

CANADIAN HOSPITAL SPECIALTIES LTD.