Events

Recall of Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medifab 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-2015-RN-00951-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00951-1
  • 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
    Medifab have identified two safety issues relating to the backrest and the tilt in space locking plunger on shuttle discovery.1. on some discovery seats the rear “s tubes” are moving in and out excessively when the backrest is rocked backwards and forwards. although some movement is normal, there is potential for the s tubes to come out of the mounting block should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. 2. on some discovery seats the tilt in space plungers are not engaging in the plastic sides. there is potential that the discovery seat may tilt back should the motor vehicle used to transport the end user in the discovery buggy be involved in an accident. there have been no reported incidents in relation to these issues.
  • Action
    A Technician or Product Consultant will contact customers to arrange a suitable time to carry out the corrective actions. For more details, please see https://www.tga.gov.au/alert/shuttle-discovery-seat . This action has been closed-out on 28/02/2018.

Device

Shuttle Discovery Seat (designed for children aged between six months and four years who have a p...
  • Model / Serial
    Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability)Product Code: 2006-0010-000Batch #: 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-**6142761738ARTG #: 160111
  • Manufacturer
    Medifab Ltd

Manufacturer

Medifab Ltd