Events

Recall of Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)

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-2016-RN-00476-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00476-1
  • 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 received reports from the field that certain ingenuity core systems running software version 3.5.4 exhibited intermittent swirl-like ring artefacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. a patient rescan may be required due to impairment of the diagnostic quality of the reconstructed images.
  • Action
    There are no proactive actions for the user. Clinical judgment should be used by the clinician to determine if the images contained in the dataset without artefacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a rescan of the patient may be required. Philips Healthcare is implementing software update version 3.5.5 to correct the above-described issue. This action has been closed-out on 30/01/2017.

Device

Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)
  • Model / Serial
    Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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