Events

Recall of Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by AngioDynamics Inc (US).

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
    21545
  • Event Initiated Date
    2017-06-15
  • 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: Getz Healthcare Limited, 2/20 Beatrice Tinsley Crescent, Albany, Auckland
  • Reason
    Manufacturer is recalling the accu2i pmta hyeprthermia system applicator as a potential failure mode has been identified of the tubing coolant line developing a leak within the applicator system which causes a "high reflected power" fault condition that makes the applicator inoperable to deliver microwave energy., hazard 1: applicator will not deliver power due to high reflected power fault condition., hazard 2: applicator's cooling line leaks cooling fluid within the applicator shaft., while the specific failure mode of the applicator not delivering the desired microwave energy would not result in any direct harm, the inserted applicator would need to be removed.
  • Action
    Product to be returned to supplier

Device

Angiodynamics Accu2i pMTA Applicator- Hyperthermia system applicator
  • Model / Serial
    Model: 900-600; 900-601; 900-602, Affected: Various Lot numbers
  • Manufacturer
    AngioDynamics Inc (US)

Manufacturer

AngioDynamics Inc (US)