Device Recall SoftPath GUI

  • Model / Serial
    SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. || 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
  • 1 Event

Manufacturer

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

7 devices with a similar name

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  • Model / Serial
    Versions 3.17 and 4.1
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and the country of Canada.
  • Product Description
    SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases.
  • Manufacturer
  • 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
  • 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
  • Model / Serial
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
  • Product Classification
  • 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
  • Model / Serial
    Version 3.17.6.3.1.
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: One hospital in NY.
  • Product Description
    SoftPath GUI version 3.17.6.3.1. || SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. || Date of Manufacture: || Version 3.17.6.3.1 06/03/2003.
  • Manufacturer
  • Model / Serial
    SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout USA and Canada.
  • Product Description
    SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). || SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). || SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). || SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
  • Manufacturer
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