Events

Recall of OXYLOG 3000 PLUS - WORKSTATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER 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
    55305
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-12
  • 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
    As part of market and product monitoring draegerwerk ag& co. kgaa the parent company of draeger medical canada inc. became aware that a batch of circuit boards with potentially faulty pressure sensors has been installed over a short period in early 2017 in oxylog 2000 plus and oxylog 3000 plus devices.

Device

OXYLOG 3000 PLUS - WORKSTATION
  • Model / Serial
    Model Catalog: 5704833 (Lot serial: ASKB-025); Model Catalog: 5704833 (Lot serial: ASKB-022); Model Catalog: 5704833 (Lot serial: ASKB-023)
  • Product Description
    OXYLOG 3000 PLUS
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.