Events

Recall of Accu2ipMTA Applicator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getz Healthcare 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-2017-RN-00759-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00759-1
  • 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
    The supplier angiodynamics has identified that the accu2i pmta applicator has the potential to not function as expected during use. the desired microwave energy will not be delivered due to coolant ingress in an electrical connection, this condition results in an error code “high reflective power” displayed on the microwave generator. please note that not all “high reflective power” error codes are a result of this failure mode, as this error code results from any instance where microwave energy is not efficiently transmitted to the tissue. although the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm to the patient; the inserted applicator will need to be removed and replaced in order to continue the procedure.
  • Action
    Customers are asked to inspect stocks, quarantine all affected units and complete the supplied Facsimile Reply Form to advise as to whether or not you still have stocks of the goods relevant to this recall.

Device

Accu2ipMTA Applicator
  • Model / Serial
    Accu2ipMTA ApplicatorProduct Codes: 900-600; 900-601; 900-602Multiple Lot NumbersARTG Number: 174514
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd