Events

Recall of HS Hospital Service SpA Amica Dual Ablation System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by HS Hospital Service SpA.

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
    21332
  • Event Initiated Date
    2017-04-18
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    A manufacturer's internal audit has discovered that a power supply unit that was installed in the generators above was not in compliance with the ce certification. due to this, the ce certification has been withdrawn from specific serial numbers only., the manufacturer has advised that electrical safety tests performed on these generators have passed and the reports are valid, and see no potential risk for patients or users.
  • Action
    Product to be returned to supplier

Device

HS Hospital Service SpA Amica Dual Ablation System

Manufacturer

HS Hospital Service SpA