Events

Recall of Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

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
    RC-2013-RN-00845-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00845-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ge healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the tec 6 and tec 6 plus vaporizers. the low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers, resulting in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. a fresh gas leak in the vaporizer does not affect delivery of the set anaesthetic agent concentration but could result in a reduction in the volume of fresh gas delivered to the breathing system. this can lead to a reduction of flow of oxygen delivered to the patient, resulting in hypoxic gas concentrations and/or a reduction in the volume of anaesthetic agent delivered to the breathing circuit which may cause light anesthesia. the fresh gas leak may release nitrous oxide (n2o) gas into the ambient air and may result in clinician exposure.
  • Action
    GE Healthcare is providing users with an addendum with directions to perform the low pressure test with the dial turned to 12%. Users are advised by GE to discontinue use of vaporizors if it fails at 12%. If the vaporizer passes, the device can continue to be used. GE will be repairing/replacing the seals on all Tec 6 and Tec 6 Plus vaporizers as a permanent fix in August 2013.

Device

Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured betwee...
  • Model / Serial
    Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)ARTG Number: 140207
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd