Events

Recall of Nordic Neuro Lab Headphones used with Siemens MRI systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-2017-RN-00761-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00761-1
  • 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 nordic neuro lab has been notified that a set of the headphone slim (hps) heated on the 1.5t scanner during an mri spinal examination, causing damage to the hps headphones. during a patient scan, the hps headphones had become warm and hence, uncomfortable for the patient to wear. subsequent investigation of the affected product showed clear indications of overheating. neither the patient nor the operator were injured. however, the headphone was sufficiently heated to potentially cause injury.
  • Action
    Siemens is advising users to immediately stop using the affected headphones until further notification. Users are to use the standard auditory system from the scanner vendor (pneumatic) until resolution of the matter. Users who require high audio quality are requested to contact Siemens customer service for information on the possibility to receive a set of NNL Ear Plugs as a temporary solution until the matter is resolved.

Device

Nordic Neuro Lab Headphones used with Siemens MRI systems
  • Model / Serial
    Nordic Neuro Lab Headphones used with Siemens MRI systemsHeadphones (HP)Catalogue Numbers: HP-1.3-20169-685 to HP-1.3-2016-693 Serial Numbers: 150694 to 150701Headphones Slim (HPS)Catalogue Numbers: HPS-1.0-2015-001 to HPS-1.0-2016-051Serial Numbers: 160052 to 160074ARTG Number: 186703
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA