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    StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034

    FDA Recall
    Terminated ·Cook Inc.·Product code FFK·January 31, 2018

    CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    CDI Blood Parameter Monitoring System 500, 500A. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·December 17, 2013

    Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·December 17, 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

    Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. 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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·August 8, 2011

    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab 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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·October 17, 2011

    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

    SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: 4.0.1.0 - 08/06/04, 4.0.1.4 - 10/18/04, 4.0.1.5 - 01/18/04, 4.0.1.6 - 12/15/04, 4.0.1.7 - 01/10/05, 4.0.1.8 - 03/29/05, 4.0.1.9 - 05/06/05, 4.0.1.13 - 01/25/06, 4.0.1.14 - 03/26/07 4.0.1.15 - 05/02/07, 4.0.1.16 - 08/22/08, 4.0.2.0 - 04/08/05, 4.0.2.1 - 08/13/08, 4.0.2.2 - 06/06/05, 4.0.2.3 - 09/19/05, 4.0.2.4 - 09/19/05, 4.0.2.5 - 09/19/05, 4.0.2.7 - 02/13/06, 4.0.2.8 - 12/12/06, 4.0.2.9 - 02/20/08, 04.2.10 - 08/13/08, 4.0.3.2 - 05/17/06, 4.0.3.3 - 09/18/06, 4.0.3.4 - 09/27/06, 4.0.3.5 - 11/29/06, 4.0.3.6 - 06/22/07, 4.0.3.7 - 03/28/07, 4.0.3.8 - 06/22/07, 4.0.3.9 - 08/03/07, 4.0.3.10 - 08/24/07, 4.0.3.11 - 09/24/07, 4.0.3.12 - 03/07/08, 4.0.3.13 - 06/13/08, 4.0.4.2 - 02/22/08, 4.0.4.3 - 05/22/08, 4.0.4.4 - 07/28/08, 4.0.4.5 - 05/04/09. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·April 1, 2009

    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

    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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·July 20, 2011

    SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·August 25, 2011

    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

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·November 26, 2014

    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.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·February 23, 2006