Events

Recall of CONTOURA BARIATRIC BED

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
    76744
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-08
  • 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
    The contoura 1000/1080 range beds are intended to be used as a bariatric medical device which is designed for patients with bmi >40. the devices have been made in accordance to the specification and cannot be descibed as defective. however if the device is used in contradiction to its intended use there is a low but existing entrapment risk for a patient being treated on this bed while being under this bmi level as not all patients are at equal risk for entrapment. in particular small lightweight patients are generally at the greatest risk for entrapment because their small physical dimensions may enhance their ability to fit into a gap in whole or in part. to help the users of these devices to always be aware of the intended use and therefore increase safety we offer additional labeling indicating that the bed is designed for patients with bmi >40. the instruction for use will contain more details on the issue and additional labels will be placed on the bed frame.

Device

CONTOURA BARIATRIC BED
  • Model / Serial
    Model Catalog: C1000 (Lot serial: ); Model Catalog: C1080 (Lot serial: )
  • Product Description
    CONTOURA BARIATRIC BED
  • Manufacturer
    ARJO CANADA INC.

Manufacturer

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