Recall of SoftReports

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

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
    Medical computers and software - Product Code LNX
  • Reason
    On 10/25/2011 scc soft computer, clearwater, fl initiated a correction on the softreports version with hot fixes 1.7199.7 or 1.7200.7. when softreports designer opened a layout, the system did not load the layout with the previously saved value in the newpage property. this caused multiple patient records to be printed on the same page. all affected clients were notified on the issue on.
  • Action
    SCC Soft Computer sent a "Correction Notification" letter dated October 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The hot fixes that were previously loaded which introduced this issue were corrected and delivered to all affected customers as a mandatory correction in hot fixes 1.7199.8 and 1.7200.8 and higher.


  • Model / Serial
    SoftReports version with Hot Fixes 1.7199.7 or 1.7200.7.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution.
  • Product Description
    SoftReports version with Hot Fixes 1.7199.7 or 1.7200.7. || SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.
  • Manufacturer


  • Manufacturer Address
    SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
  • Manufacturer Parent Company (2017)
  • Source