Events

Recall of Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.

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
    60451
  • Event Risk Class
    Class 2
  • Event Number
    Z-0355-2012
  • Event Initiated Date
    2011-06-13
  • Event Date Posted
    2011-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105437
  • 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 06/13/2011, scc soft computer initiated a correction on the following softpath gui versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. a client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. parts a through d were present as well as part f, however, part e diagnosis was missing for one of the patient reports. all affected clients wer.
  • Action
    SCC Soft Computer initiated a Field Correction on June 13, 2011. All customers with affected software have been notified of this issue. SCC recommends until the corrected patch is loaded to temporarily use one of the following alternative working solutions: 1. Use MS Word Editor functionality within SoftPath application for creating patient reports. In order to ensure Text Control editor is not inadvertently activated, the templates for Text Control editor will be deleted and reinstalled at the clients request by their SCC representative after receipt of the correction. 2. In Report Template set-up, the bottom margin should be made slightly larger than the size of the footer plus its distance from the bottom page border. For further explanation, please consult your SCC representative for further details, or call (727) 789-0100.

Device

Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
  • Model / Serial
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
  • Product Description
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. || 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