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Terminated

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 Z-0362-2012 · Posted 2011-12-02

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2011-10-25
Date Terminated2012-03-16
Product Quantity5

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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