SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. 23.1:BK040048 23.2:BK080020 25.0:BK090017 The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.
This recall has been terminated (originally issued November 15, 2010).
- Company
- Scc Soft Computer
- Recall Initiated
- June 22, 2010
- Posted
- November 15, 2010
- Terminated
- September 5, 2012
- Recall Number
- Z-0362-2011
- Quantity
- 30
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient history reports using Patient>Reports>Batch Reports>History Report option in SoftBank with SoftReports activated for patient reports, when the report is generated for more than one patient ALL of the results for the qualif
Distribution
Worldwide distribution: U.S. and country of Canada.
Lot / Code Info
Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
Root Cause
Software design
Action Taken
SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments. If you have any questions, contact (727) 789-0100.