Events

Recall of Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1

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-2014-RN-01100-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01100-1
  • 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 became aware through a customer complaint that while performing a cct examination on an ingenuity ct system, the first image was marked as “last shot” rather than the actual “last shot” acquired. after the clinician pressed the pedal for first exposure, images were displayed as the “last shot”. subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labelled as the “last shot”. eventually all images appeared. during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have real-time feedback of needle placement when the needle is near vital structures (major blood vessel, organ, etc).
  • Action
    Philips is advising that affected users should check their CCT exam card and correct if the issue exists as described in the instructions supplied with the customer letter. A Philips Field Service Engineer will contact customers to schedule the software update at their site to permanently correct the issue. This action has been closed-out on 05/09/2016.

Device

Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option ...
  • Model / Serial
    Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1ARTG number: 98868
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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