Events

Recall of DATEX-OHMEDA D-TEC-6 PLUS ANESTHETIC VAPORIZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DATEX-OHMEDA 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
    91752
  • Event Risk Class
    II
  • Event Initiated Date
    2001-07-31
  • 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
    A compatibility issue with the drager julian anesthesia workstation in that under certain conditions the vaporizer will provide "no output" and a visual alarm and cease delivery of anesthetic agent.

Device

DATEX-OHMEDA D-TEC-6 PLUS ANESTHETIC VAPORIZER
  • Model / Serial
    Model Catalog: 1107-9206-000 (Lot serial: ZE03018.); Model Catalog: 1107-9206-000 (Lot serial: ACZD51003 ACZD51028 ACZD5103); Model Catalog: 1107-9206-000 (Lot serial: 4 ACZD52008 AEZE03001 AEZE0); Model Catalog: 1107-9206-000 (Lot serial: 3005 ACZD51004 ACZD52003 AE)
  • Product Description
    DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAP
  • Manufacturer
    DATEX-OHMEDA INC.

Manufacturer

DATEX-OHMEDA INC.
  • Manufacturer Address
    MADISON
  • Source
    HC