Events

Recall of IMPAX CARDIOVASCULAR - CLINICAL REVIEW STATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGFA HEALTHCARE 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
    88298
  • Event Risk Class
    I
  • Event Initiated Date
    2013-09-30
  • 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
    Agfa healthcare recently uncovered an issue in the ocr service product which was recently deployed with the impax cv 7.8su3 product at your facility. agfa has identified that pediatric measurements for height and weight are not correctly imported during ocr measurement import. specifically the value for weight is being inserted into the height field and the weight field is empty.

Device

IMPAX CARDIOVASCULAR - CLINICAL REVIEW STATION
  • Model / Serial
    Model Catalog: 7.8 (Lot serial: 7.8 SU3)
  • Product Classification
    Radiology Devices
  • Product Description
    IMPAX CV 7.8 SU3 - OCR Service for Pediatric measurement import
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC