Devices

Device Recall SoftLab

  • Model / Serial
    SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Country of: Canada.
  • Product Description
    SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
  • 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

6 devices with a similar name

Learn more about the data here

Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1
  • Model / Serial
    4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
  • Product Description
    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
  • Manufacturer
    SCC Soft Computer
Device Recall SoftLab
  • Model / Serial
    Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
  • Product Description
    SoftLab Software || Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
  • Manufacturer
    Soft Computer Consultants, Inc.
Device Recall Softlab
  • Model / Serial
    Softlab with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Sold throughout US and Canada.
  • Product Description
    SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
  • Manufacturer
    SCC Soft Computer
Device Recall SoftLab GUI versions 4.0.2.84.0.2.10; 4.0.3.124.0.3.13; and 4.0.4.14.0.4.4.
  • Model / Serial
    SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-- USA ( nationwide) and Canada.
  • Product Description
    SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.
  • Manufacturer
    SCC Soft Computer
Device Recall SoftLab
  • Model / Serial
    SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of: Canada.
  • Product Description
    SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. || Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
  • Manufacturer
    SCC Soft Computer
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