Events

Recall of Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtel 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-2013-RN-01014-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01014-1
  • 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
    The manufacturer, magstim has identified a manufacturing non-conformity on a single 9784-00, magstim 90mm high power coil. the nature of the non-conformance is the omission of the insulating sleeving that is normally applied over the two solder joints between the coil winding and the red and black conductors in the coil cable. although the coil passed the safety tests and functional checks, the non-conformance resulted in an increase in the risks associated with the use of the coil and could have led to complete failure of the coil during usage. the failure mode would be such that a loud bang would be produced and the coil would cease to function. there could also be damage to the stimulator to which the coil was connected.
  • Action
    Medtel is requesting users to stop using the coils. Product can be returned to Medtel for replacement with unaffected stock.

Device

Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cor...
  • Model / Serial
    Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)Part Number: 9784-00Serial Numbers: 2687, 2676ARTG Number: 136823
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA