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    ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes

    FDA Recall
    Terminated ·Baxter Corporation Englewood·Product code LNX·December 3, 2013

    SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·June 23, 2010

    SoftPath GUI Versions 3.17 and 4.1. SCC Soft Computer 5400 Tech Data Drive, Clearwater, FL 33760. Manufactured: Version 3.17.7.6 10/23/2003

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·December 30, 2003

    BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***

    FDA Recall
    Terminated ·Varian Brachytherary Virginia·Product code LNX·October 31, 2003

    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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·March 22, 2011

    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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·March 11, 2004

    Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Dates: 4.0.2.38.1 06/15/07 4.02.39.2 06/29/07, 4.02.40.1 07/19/07, 4.02.41.1 08/20/07. The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·October 5, 2007

    ORCHESTRA/ORCHESTRA PLUS Programmer

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Saluggia, VC Italy·Product code LNX·November 20, 2013

    SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·August 4, 2006

    SoftID.NET versions 2.0.0.6 - 2.0.0.19. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·August 28, 2009

    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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·June 13, 2011

    SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·July 19, 2010

    Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·November 30, 2004

    SoftPath GUI Releases 3.17 through 4.1.0. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: Version 3.17.5 10/14/2003. Version 3.17.6 03/28/2003. Version 3.17.7 07/02/2003. Version 3.17.8 03/03/2004. Version 4.1.0 07/03/2003. Version 4.1.1 10/03/2003. Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·March 28, 2007

    SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·June 8, 2006

    Clinician Workstation Software, product code 2M5042

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LNX·March 10, 2005

    SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·October 25, 2011

    Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.

    FDA Recall
    Terminated ·Baxa Corporation·Product code LNX·January 19, 2009

    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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·May 3, 2011

    Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code LNX·August 29, 2005