Events

Recall of Medifab Shuttle Discovery System

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

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
    19187
  • Event Initiated Date
    2015-10-06
  • 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: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
  • Reason
    The manufacturer has identified two potential issues relating to the backrest and the tilt in space locking plunger should the vehicle used to transport the end user in the discovery buggy be involved in an accident., 1/ there is potential for the s tubes to come out of the mounting block, 2/ there is potential that the discovery seat may tilt back due to the tilt in space plungers not being engaged in the plastic slides.
  • Action
    Product to be modified

Device

Medifab Shuttle Discovery System
  • Model / Serial
    Model: 2006-0010-000, Affected: JS-06-14-DS-**, JS-15-14-DS-**, JS-18-14-DS-**, JS-23-14-DS-**, JS-45-14-DS-**, JS-46-14-DS-**, ML-8-15-DS-**, ML-13-15-DS-**, ML-16-15-DS-**, ML-17-15-DS-**, ML-18-15-DS-**, 61427, 61738
  • Manufacturer
    Medifab Medical Fabrication

Manufacturer

Medifab Medical Fabrication