Events

Recall of MEDRAD OVERHEAD COUNTERPOISE SYS FOR MARK & CT INJECTORS *155731

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
    152582
  • Event Risk Class
    II
  • Event Initiated Date
    2005-10-18
  • 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
    The overhead counterpoise system ii has the potential to fall due to failure of a retaining ring which may result in injury to the clinician or patient.

Device

MEDRAD OVERHEAD COUNTERPOISE SYS FOR MARK & CT INJECTORS *155731
  • Model / Serial
    Model Catalog: OCS 135A (Lot serial: 3010552); Model Catalog: OCS 155A (Lot serial: 3010552); Model Catalog: OCS 115A (Lot serial: 3010552); Model Catalog: OCS 155A (Lot serial: 3010551); Model Catalog: OCS 135A (Lot serial: 3010551); Model Catalog: OCS 125A (Lot serial: 3010551); Model Catalog: OCS 115A (Lot serial: 3010551); Model Catalog: OCS 155A (Lot serial: 3010550); Model Catalog: OCS 135A (Lot serial: 3010550); Model Catalog: OCS 125A (Lot serial: 3010550); Model Catalog: OCS 115A (Lot serial: 3010550); Model Catalog: OCS 155A (Lot serial: 3010549); Model Catalog: OCS 135A (Lot serial: 3010549); Model Catalog: OCS 125A (Lot serial: 3010549); Model Catalog: OCS 115A (Lot serial: 3010549); Model Catalog: OCS 155A (Lot serial: 3010548); Model Catalog: OCS 135A (Lot serial: 3010548); Model Catalog: OCS 125A (Lot serial: 3010548); Model Catalog: OCS 115A (Lot serial: 3010548); Model Catalog: OCS 155A (Lot serial: 3010547); Model Catalog: OCS 135A (Lot serial: 3010547); Model Catalog: OCS 125A (Lot serial:
  • Product Description
    OVERHEAD COUNTERPOISE SYSTEM II
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

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