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
    126874
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-28
  • 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 device is designed to generate an audible and visual alarm when the measured value for spo2 falls below the alarm threshold set for the spo2 low alarm by the clinician. if the measured value continues to fall the device is designed to continue to generate a spo2 low alarm. but for devices with software version 1.03 if the sp02 measured value drops below the spo2 low alarm threshold by more than 10 percent the audible and visual alarm for sp02 low will stop. if the value measured rises again the alarm will be generated again as soon as the measured value is ten percent or less below the spo2-low alarm threshold. all displayed measurements of values and spo2 curves are performing as designed at any time.

Device

ZEUS INFINITY EMPOWERED (ANESTHESIA WORKSTATION)
  • Model / Serial
    Model Catalog: MK04000 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ZEUS IE ANESTHESIA WORKSTATION
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.