Events

Recall of Device Recall SoftPath GUI

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
    Recall
  • Event ID
    60420
  • Event Risk Class
    Class 2
  • Event Number
    Z-0209-2012
  • Event Initiated Date
    2011-07-13
  • Event Date Posted
    2011-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105376
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Soft computer, clearwater, fl, initiated a correction on the following softpath gui versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. softpath architecture does not correctly handle ap macros and data fields inside report sections that are stored in the database. improper information can be displayed in all places where the diagnosis from the database is read and displayed.
  • Action
    The firm, SCC Soft Computer, sent a "CORRECTION COMMUNICATION" notice on July 13, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to restrict security access to the template set-up files and to acknowledge receipt of the notice; grant SCC personnel permission to check their report templates and correct any that are affected; indicate if they wish to schedule the utility to be run and if they would like to have the SoftWeb parameter PathPDFLinkOnly set to "Y". SCC will review the templates on the customers systems; discuss any irregularities requiring change and move or remove AP macros and data elements as needed. If you have any questions, contact the Director of Quality Management at (727)789-0100.

Device

Device Recall SoftPath GUI
  • Model / Serial
    SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; country of Canada.
  • Product Description
    SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
  • Manufacturer
    SCC Soft Computer

Manufacturer

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