Events

Recall of ProGrade Rel.1x Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-00135-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00135-1
  • 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
    If the wifi connection between the skyplate detector and hp transfer point is weak, an image may fail to transfer from the skyplate detector to the system. the image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. to continue, the operator can reset the skyplate detector by removing its batteries, but the acquired image is lost and a re-take is necessary.
  • Action
    Philips plans to release a new HP firmware to the installed base. In addition the existing Access Point Hardware in the field needs to be patched. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented.

Device

ProGrade Rel.1x Systems

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA