Events

Recall of INGENUITY CT 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
    54018
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-19
  • 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
    During a contact renewal the provider of the antivirus software it was discovered that the current software versin was due to expire on february 15 2015. with the expiration on february 15 2015 this left the systems with no active virus protection which does not meet the product performance specification. it is important to note that systems will function as intended once the software expires.

Device

INGENUITY CT SYSTEM
  • Model / Serial
    Model Catalog: 728326 (Lot serial: More than 10 - contact manuf.); Model Catalog: 728321 (Lot serial: More than 10 - contact manuf.); Model Catalog: 728323 (Lot serial: More than 10 - contact manuf.)
  • Product Description
    INGENUITY CT SYSTEM
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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