Company:SCC Soft Computer
Date of Enforcement Report 7/27/2011
Class ll:
PRODUCT
ElekSoftReports 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. 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). Recall # Z-2714-2011.
REASON
Potential hazard – when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter dated June 9, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide and Canada
