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U.S. Department of Health and Human Services

Class 2 Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.

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  Class 2 Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. see related information
Date Initiated by Firm June 22, 2010
Date Posted November 15, 2010
Recall Status1 Terminated 3 on September 05, 2012
Recall Number Z-0362-2011
Recall Event ID 56872
Product Classification Software, blood bank, stand alone products - Product Code MMH
Product 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.
Code Information Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 30
Distribution Worldwide distribution: U.S. and country of Canada.
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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