Events

Recall of STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM

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
    69529
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-12
  • 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
    A customer complaint was received indicating that the contrast phase of a p3t (personalize patient protocol technology) generated diagnostic protocol was skipped. during an analysis of the issue it was found that the protocol generated via p3t was not achievable by the stellant with certegra work station injector. the system informed the user via pop-up message "insufficient volume for programmed rate". the protocol on the injector head would then revert to the previous injection protocol but the display would continue to reflect the unachievable protocol to the technician. this could lead to a patient being injected with a different protocol than the technician intended. this situation only arises in stellant systems with certegra work stations with sofware version 100.60 or newer that have p3t software enabled.

Device

STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM
  • Model / Serial
    Model Catalog: 3032458 (Lot serial: 11036); Model Catalog: 3032458 (Lot serial: 11047); Model Catalog: 3032458 (Lot serial: 10493); Model Catalog: 3032458 (Lot serial: 10962); Model Catalog: 3032458 (Lot serial: 11295)
  • Product Description
    STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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