Events

Recall of STELLANT CT INJECTOR SYSTEM - P3T CARDIACFLOW SOFTWARE UPGRADE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER MEDICAL CARE INC..

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
    87603
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    1-when p3t cardiac protocols are programmed with saline test inject and used in conjunction with isi 700 or isi 800 products and the stellant ct injection system the pre-diagnostic protocol must include a transit bolus. 2-a defect in sw version 103.0 and 104.0 of the stellant ct injection systems may cause isi 700 accessory to incorrectly trigger bolus tracking on a philips ct system for p3t cardiac protocol.

Device

STELLANT CT INJECTOR SYSTEM - P3T CARDIACFLOW SOFTWARE UPGRADE
  • Model / Serial
    Model Catalog: 3007301 (Lot serial: ); Model Catalog: 3010432 (Lot serial: ); Model Catalog: 3014849 (Lot serial: )
  • Product Description
    Stellant CT Dual Injector Systems P3T
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Manufacturer Address
    INDIANOLA
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC