Devices

Device Recall SoftPath

  • Model / Serial
    Version 4.3.0.8 Release date: 07/31/2009 - Present;  Version 4.3.0.9 Release date: 11/23/2009 - Present;  Version 4.3.0.10 Release date: 09/20/2010- Present;  Version 4.3.0.11 Release date: 11/11/2010- Present;  Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present;  Version 4.3.0.15 Release date: 09/17/2013- Present;  Version 4.4.0.1 Release date: 12/13/2013 - Present;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide and CANADA.
  • Product Description
    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
  • Manufacturer
    SCC Soft Computer
  • 1 Event

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

10 devices with a similar name

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Device Recall SoftPath GUI Release Software Versions 3.17 and 4.1
  • Model / Serial
    Versions 3.17 and 4.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    SCC Soft Computer
Device Recall SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
  • Model / Serial
    Version 1.2, 2.1, 2.2 and 2.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to 106 consignees located throughout the United States and Canada.
  • Product Description
    Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3.
  • Manufacturer
    SCC Soft Computer
Device Recall SoftPath
  • Model / Serial
    Releases 1.2, 2.1, and 2.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
  • Manufacturer
    SCC Soft Computer
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
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
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