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
    65217
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-30
  • 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 rf suppression ferrite has to be added to the ethernet cable to consistently reduce emissions below the allowed limit for the stellant d dual syringe injector with certegra workstation causing a misbranding of the product.

Device

STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM
  • Model / Serial
    Model Catalog: SCT-310 (Lot serial: SN 10493 10478 10473); Model Catalog: SCT-310 (Lot serial: SN 11295 10962 10516); Model Catalog: SCT-310 (Lot serial: SN 10409 10430 11036); Model Catalog: SCT-310 (Lot serial: SN 11047)
  • Product Description
    Medrad Stellant with Certegra Workstation
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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