Recall of Device Recall CRS Remote

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGFA Corp..

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    cardiovascular information system. - Product Code LLZ
  • Reason
    A discrepancy in the validation testing which resulted in the product not performing as intended.
  • Action
    AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.


  • Model / Serial
    Model Number CV7.8 Catalog Number CM 60+ 00091915, Software Version CRS Remote_7.8_HL
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
  • Manufacturer


  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source