Events

Recall of Ingenuity TF PET/CT

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-2013-RN-00891-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00891-1
  • 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
    Three issues were identified that may cause a situation requiring a patient rescan:1. after a surview and low dose ct scan, the system does not show the "enable" button prompt to allow the user to begin the pet scan resulting in the inability to perform the pet scan.2. when navigating to the series field value within the scan parameters pane, the series field value will accept certain characters resulting in the failure of the system to properly process the data and provide a reconstructed image.3. a pet reconstruction failure as a result of an incomplete study.
  • Action
    Philips Healthcare will be installing a software update v 4.0.3. Until software is upgraded, Philips Healthcare advises users to perform workarounds identified in letter.

Device

Ingenuity TF PET/CT
  • Model / Serial
    Ingenuity TF PET/CTModel number 882456 Software version: 4.0.0.26636 04-Jan-2013Serial numbers: 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018, 2019ARTG number: 118077
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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