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U.S. Department of Health and Human Services

Class 2 Device Recall SoftReports

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  Class 2 Device Recall SoftReports see related information
Date Initiated by Firm October 25, 2011
Date Posted December 02, 2011
Recall Status1 Terminated 3 on March 16, 2012
Recall Number Z-0362-2012
Recall Event ID 60416
Product Classification Medical computers and software - Product Code LNX
Product 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.
Code Information SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.
Recalling Firm/
Manufacturer
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact Kathryn Branca
727-789-0100
Manufacturer Reason
for Recall
On 10/25/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. When SoftReports Designer opened a layout, the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page. All affected clients were notified on the issue on
FDA Determined
Cause 2
Software design
Action SCC Soft Computer sent a "Correction Notification" letter dated October 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The hot fixes that were previously loaded which introduced this issue were corrected and delivered to all affected customers as a mandatory correction in hot fixes 1.7199.8 and 1.7200.8 and higher.
Quantity in Commerce 5
Distribution Nationwide Distribution.
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.
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