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U.S. Department of Health and Human Services

Class 2 Device Recall SoftReports versions 1.1.6.x and 1.1.7.x

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  Class 2 Device Recall SoftReports versions 1.1.6.x and 1.1.7.x see related information
Date Initiated by Firm June 23, 2010
Date Posted June 30, 2011
Recall Status1 Terminated 3 on July 26, 2012
Recall Number Z-2714-2011
Recall Event ID 56848
Product Classification Medical computers and software - Product Code LNX
Product 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).
Code Information Versions 1.1.6.x and 1.1.7.x.
Recalling Firm/
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Kathryn Branca
Manufacturer Reason
for Recall
SCC Soft Computer is issuing a correction for SoftReports Versions 1.1.6.x released 02/2008 and 1.1.7.x released 06/2008. Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header.
FDA Determined
Cause 2
Software design
Action SCC Soft Computers sent a "RISK TO HEALTH NOTIFICATION TASK" letter dated June 9, 2010 to affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were offered an upgrade or hot fix. The letter requested acknowledgement of receipt of the task notification and permission to install the hot fix.
Quantity in Commerce 49
Distribution Worldwide Distribution--USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.