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.
This recall has been terminated (originally issued December 2, 2011).
- Company
- Scc Soft Computer
- Recall Initiated
- October 25, 2011
- Posted
- December 2, 2011
- Terminated
- March 16, 2012
- Recall Number
- Z-0362-2012
- Quantity
- 5
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution.
Lot / Code Info
SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.
Root Cause
Software design
Action Taken
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.