Events

Recall of Ultrasound Transducer Norway TOE

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Vingmed Ultrasound AS.

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
    22553
  • Event Initiated Date
    2018-02-07
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    The tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans., further testing has identified a need for clarification of previously communicated disinfection guidance for ge tee probes. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe.
  • Action
    Manufacturer to issue advice regarding use

Device

Ultrasound Transducer Norway TOE
  • Model / Serial
    Model: TEE probe models 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS, Affected:
  • Manufacturer
    GE Vingmed Ultrasound AS

Manufacturer

GE Vingmed Ultrasound AS