Company: SCC Soft Computer..
Date of Enforcement Report 12/22/2010
Class ll:
PRODUCT
SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. 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. Recall # Z-0362-2011
REASON
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 qualified patients are displayed under each patient’s header.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, via the proprietary communication software entitled “Risk-to-Health Notification Task Verbiage” dated June 11, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide, Canada
