Events

Recall of ZEUS INFINITY EMPOWERED (ANESTHESIA 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
    44245
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-31
  • 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
    Firm became aware of an event in which a 38mm pole broke due to excessive load. it was found that the draeger infinity acute care system was mounted on the optional 38mm pole in a way not validated by draeger and the maximum load of 13 kg was exceeded. if the weight of the equipment mounted on the 38mm pole exceeds 13kg it could potentially bend break or fall on a patient user or bystander.

Device

ZEUS INFINITY EMPOWERED (ANESTHESIA WORKSTATION)
  • Model / Serial
    Model Catalog: MK04000 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    ZEUS IE ANESTHESIA WORKSTATION
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.