Events

Recall of OXYLOG 3000 SYSTEM - MAIN UNIT

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
    47068
  • Event Risk Class
    I
  • Event Initiated Date
    2010-08-17
  • 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
    Patients have been inadequately ventilated because the dead space of the breathing circuit was not completely considered by the user when setting the ventilation parameters. the information for use (ifu) for the oxylog 3000 devices delivered from september 2008 contains additional warnings and cautions. a safety notice with the ifu amendment will be sent out to users who own affected oxylog 3000. no patient injury has been reported in relation to that dead space issue.

Device

OXYLOG 3000 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 2M86955 (Lot serial: SRZA-0128); Model Catalog: 2M86955 (Lot serial: SRYA-0014); Model Catalog: 2M86955 (Lot serial: SRYA-0195); Model Catalog: 2M86955 (Lot serial: SRYB-0074); Model Catalog: 2M86955 (Lot serial: SRYK-0068); Model Catalog: 2M86955 (Lot serial: SRYK-0069); Model Catalog: 2M86955 (Lot serial: SRYK-0131); Model Catalog: 2M86955 (Lot serial: SRYK-0132); Model Catalog: 2M86955 (Lot serial: SRYK-0133); Model Catalog: 2M86955 (Lot serial: SRYK-0134); Model Catalog: 2M86955 (Lot serial: SRZB-0059)
  • Product Description
    OXYLOG 3000
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.