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
    49699
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-05
  • 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
    Through a review of complaint data it was identified that the workflow supported by versions 4.21 4.31 and 4.32 of the certegra informatics point-of-care software may fail intermittently to send data captured from the injection system to the institution's pacs system. this failure to send data is more likely to occur when the certegra workstation is left on for more than 24 consecutive hours.

Device

STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM
  • Model / Serial
    Model Catalog: SCT-322 (Lot serial: More than 10 contact manuf.); Model Catalog: SCT-321 (Lot serial: More than 10 contact manuf.)
  • 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