Events

Recall of Amtech Penlight with Pupil Gauge

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Amtech Medical 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
    18937
  • Event Initiated Date
    2015-07-28
  • 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: Amtech Medical Ltd, 281 Heads Road, Wanganui 4501
  • Reason
    A faulty on-off switch is causing premature draining of the batteries.
  • Action
    Product to be returned to supplier

Device

Amtech Penlight with Pupil Gauge
  • Model / Serial
    Model: DI333HP, Affected: All units supplied between 1-Apr-2015 and 30-Jun-2015
  • Manufacturer
    Amtech Medical Ltd

Manufacturer

Amtech Medical Ltd