Events

Recall of DATEX-OHMEDA TEC 6 ANESTHETIC VAPORIZOR

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
    14731
  • Event Risk Class
    II
  • Event Initiated Date
    1998-06-24
  • 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
    Fresh gas leak developed between the vaporizer and the manifold caused by the rear cover of the vaporizer being distorted and could become weakened during label removal portion of the service process.

Device

DATEX-OHMEDA TEC 6 ANESTHETIC VAPORIZOR
  • Model / Serial
    Model Catalog: (Lot serial: ACTY42113 42271 43291); Model Catalog: (Lot serial: 45249 AC08121); Model Catalog: (Lot serial: ACTX33075 40159 40271); Model Catalog: (Lot serial: 05064 17041 31039 33058); Model Catalog: (Lot serial: 47162 50147 ACTX02050); Model Catalog: (Lot serial: ); Model Catalog: (Lot serial: 26129 34090 34110 36085); Model Catalog: (Lot serial: 23223 23327 25120 26048); Model Catalog: (Lot serial: 21286 21428 23092 23107); Model Catalog: (Lot serial: 07182 09114 09119 18232); Model Catalog: (Lot serial: ACTW03045 05501 07127); Model Catalog: (Lot serial: 36153 38160 39466 43115)
  • Product Description
    TEC 6 ANESTHETIC VAPORIZER
  • Manufacturer
    DATEX-OHMEDA INC.

Manufacturer

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