Events

Recall of Novacell Battery Charger supplied with the BLS-1000 Light Source set (light source for endoscopic procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Vision Sciences Australia 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-01091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01091-1
  • 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
    Ashmed has been made aware of the potential for over-heating and possible burning or bursting of lithium-ion batteries with the affected vision sciences battery charger model. when the battery is unintentionally placed by the user in a reversed polarity position for charging, the anode pin on the charger may come into contact with the negative polarity of the battery causing overheating.
  • Action
    AshMed Pty Ltd is requesting their customer to inspect their Vision Sciences battery charger to determine if they are affected by the issue. Affected units are to be immediately quarantined. AshMed Pty Ltd will arrange for replacement with unaffected chargers.

Device

Novacell Battery Charger supplied with the BLS-1000 Light Source set (light source for endoscopic...
  • Model / Serial
    Novacell Battery Charger supplied with the BLS-1000 Light Source set (light source for endoscopic procedures)Model number of battery charger: NV-LC02
  • Manufacturer
    Vision Sciences Australia Pty Ltd

Manufacturer

Vision Sciences Australia Pty Ltd
  • Source
    DHTGA