Events

Recall of neoBLUE LED Phototherapy Lights (2nd Generation)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Paragon 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-00466-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00466-1
  • 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 neoblue 2 systems were manufactured using individual leds of higher intensity output than the original product specification. to compensate for this higher intensity, customers were previously advised to increase the distance between the phototherapy light and the patient. the neoblue 2 light is now being recalled and replaced with the current generation light.
  • Action
    Paragon Care is requesting customers identify if they have affected stock by checking for a black band around the light enclosure base. If so, users are requested to record the Serial number (located on the back panel of the light enclosure) on the reply form and return the completed form in order to receive a free replacement. Users are then advised to place the affected light in the box which contained the replacement prior to its return to Paragon Care.

Device

neoBLUE LED Phototherapy Lights (2nd Generation)

Manufacturer

Paragon Healthcare Pty Ltd