Events

Recall of B. Braun Electrosurgical system generator, general-purpose

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Aesculap AG.

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
    21005
  • Event Initiated Date
    2017-01-20
  • 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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
  • Reason
    In exceptional cases the devices might have a functional disorder, which will be detected by the device itself and signaled to the user unmistakably by way of an error message (error f008, code 26) and an acoustic alarm. the generator will be set into a safe mode in which no power will then be released.
  • Action
    Product to be modified

Device

B. Braun Electrosurgical system generator, general-purpose
  • Model / Serial
    Model: , Affected: GN200
  • Manufacturer
    Aesculap AG

Manufacturer

Aesculap AG