Events

Recall of Ingenuity Core128 CT 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-00597-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00597-1
  • 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
    During production two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. the nonconforming fasteners may have been used to manufacture ingenuity ct systems. the fasteners are used to secure sub-components of the adjustment cradle within the system gantry. analysis has concluded that the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. however given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued). since the adjustment cradle requires periodic adjustment, it is expected that the nonconforming fasteners would require re-torqueing at some point during the system’s lifetime. repeated re-torqueing of the stainless steel fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. there have been no reports of injuries.
  • Action
    Philips is advising users that a field service technician will replace the affected screws on all affected systems.

Device

Ingenuity Core128 CT System

Manufacturer

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