Events

Recall of Vadi Heater

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AHC Solutions 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-2018-RN-00041-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00041-1
  • 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
    Ahs solutions p/l has been made aware of an issue regarding overheating of vadi heater vh220 causing shrinkage of the filter due to dysfunction of the cut-off switch. the root cause analysis found that the dysfunction of the switch is due to the distance from the tape to glue the switch to the heating scroll not being attached closely enough. as a result, there is a gap between switch and aluminium heating scroll, which, after a long term use, can damage the switch. the damaged switch will therefore be unable to control the temperature, causing overheating which deforms the filter.
  • Action
    AHC Solutions is advising users to dispose of VH220 heaters that are currently in use. Customers will be provided with replacement heaters.

Device

Vadi Heater
  • Model / Serial
    Vadi Heater Part Number: VH220ARTG Number: 212166 (AHC Solutions Pty Ltd - Filter, ventilator)
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd