Events

Recall of INFINITY MODULAR MONITOR (7000 SERIES)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL SYSTEMS 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
    25568
  • Event Risk Class
    II
  • Event Initiated Date
    2001-12-05
  • 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
    Software defect in the drug titration calculation feature in french and german languages. potential for using drug titration readings above and below the correct calculated value.

Device

INFINITY MODULAR MONITOR (7000 SERIES)
  • Model / Serial
    Model Catalog: (Lot serial: Cat. # 59 46 731)
  • Product Description
    Infinity Modular Monitor 9000 series
  • Manufacturer
    DRAEGER MEDICAL SYSTEMS INC.

Manufacturer

DRAEGER MEDICAL SYSTEMS INC.
  • Manufacturer Address
    DANVERS
  • Source
    HC