Events

Recall of SIM System with SIM dock power supply model Franmar FRA012-S05-I

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Simavita Aust Pty 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-00076-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00076-1
  • 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
    Simavita has recently received notification from their third party supplier that the plug adaptor, which is provided together with the sim dock power supply, has a design fault. under some circumstances, one of the pins from the plug adaptor may detach during removal from the power point and remain protruding from the power point creating an electrocution hazard.
  • Action
    Customers are advised to:- 1. Identify the location of the SIM dock power supplies at their facility; 2. DO NOT unplug any of these power supplies that are currently plugged into a power point. The risk of electrocution only occurs where the pin has become detached from the plug adaptor & remains in the power point. 3. Immediately notify internal maintenance personnel in order to carry out safe removal of the power supplies from each outlet. Following safe removal all units must be quarantined until the product correction has been carried out; 4. Where one of these power supplies is not currently plugged into a power point, DO NOT plug in & use that power supply & quarantine the units as per internal procedures; 5.Immediately inspect any power points for the above fault in locations where it is known this device is regularly used & notify appropriate internal personnel in the event this anomaly is identified; and 6. Share this Notification internally to all appropriate staff. This action has been closed-out on 18/07/2016.

Device

SIM System with SIM dock power supply model Franmar FRA012-S05-I
  • Model / Serial
    SIM System with SIM dock power supply model Franmar FRA012-S05-I ARTG Number: 227029
  • Manufacturer
    Simavita Aust Pty Ltd

Manufacturer

Simavita Aust Pty Ltd