Events

Recall of Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)

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-01541-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01541-1
  • 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 a software issue causing pet reconstructions to fail intermittently. it was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. this error has been found to occur in two scenarios resulting in acquisition data that will not be able to be reconstructed and will therefore be unusable: 1) when the system operator cancels an acquisition2) couch position requests within the software sequence were delayed a. the error occurs intermittently, but has been found to occur more frequently when the gantry’s network is heavily loaded with multiple retrospective reconstructions running in parallel. b.The error manifests to the technologist by an error message and failed status on the reconstruction monitor and the error message “result {0} failed to reconstruct” on the acquisition workflow window during reconstruction after the patient scan has been completed.
  • Action
    It is recommended that the technologist follow the Warning provided in the Instructions for Use - System Information for Ingenuity TF 459800079321 Rev B, Section 2 Safety Guidelines, pg 2-17 and that the patient remains in the original scan position until reconstructed images are verified. Philips will be releasing a correction for this issue. A Philips Field Service Engineer will contact users to schedule the update.

Device

Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645)

Manufacturer

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