Events

Recall of Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)

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-00233-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00233-1
  • 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 has identified that there may be an issue with acquisition if the addonics mass storage device (msd) provided with the system is connected to the console and powered on during an acquisition.Following a period of inactivity, the addonics msd may cause the acquisition console to become unresponsive. this may prevent an acquisition from proceeding resulting in a potential re-scan being required.
  • Action
    Philips is advising users to not view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Philips will be providing an updated Mass Storage Device to all affected customer to correct the issue.

Device

Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)
  • Model / Serial
    Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)PET/CT System Model Number: 882442MSD Serial Number: 2090ARTG Number: 292543(Philips Electronics Australia - Combination diagnostic imaging system, PET/CT)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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