Recall Z-1097-2017— Soft Computer Consultants, Inc.
Class II · Terminated
Class II FDA medical device recall by Soft Computer Consultants, Inc., initiated 2016-10-06, terminated 2019-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.. Reason: Software error. Potential for incorrect results.
- Recalling firm
- Soft Computer Consultants, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-06
- Terminated
- 2019-08-21
- Firm location
- Clearwater, FL, United States
Product description
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
Reason for recall
Software error. Potential for incorrect results
Data sourced from openFDA. This site is unofficial and independent of the FDA.