FDA Medical Device Recalls (openFDA)
SCC Soft Computer: 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.
- Recall number
- Z-0362-2011
- Recalling firm
- SCC Soft Computer
- 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.
- Status
- Terminated
- Initiated
- 2010-06-22
- Posted
- 2010-11-15
- Terminated
- 2012-09-05
- Reason
- 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
- Root cause
- 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
- 30
- Distribution
- Worldwide distribution: U.S. and country of Canada.
- Lot, serial or model codes
- Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MMH
- Firm FEI
- 1000307651
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28