Events

Recall of DigitalDiagnost Release 3.1.x

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-2017-RN-00848-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00848-1
  • 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
    Philips healthcare has identified a firmware anomaly inside the detector (4343rc) that can cause the detector to appear ready for acquisition at very short time intervals while it actually is not, resulting in incorrectly acquired x-ray images. a retake of the image is necessary if the captured corrupt image is clinically unusable, leading to additional exposure for the patient.
  • Action
    Philips is requesting that users: -Read the supplied notice. -Distribute the supplied notice to all users of the device in your facility. -Complete the response form and return it to Philips via fax/email within 3 business days as per the instructions in the customer letter. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented. Should users need to communicate with Philips with regard to this matter, reference Field Change Order 71200170.

Device

DigitalDiagnost Release 3.1.x

Manufacturer

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