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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Soft Computer Consultants, Inc.: Software error. Potential for incorrect results; Software error. Potential for incorrect results

Agency Publication Date: January 26, 2017
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Affected Products

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.

Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0

Product: Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

Version: 35.5.2.0, 25.5.3.0, 25.5.3.1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76046
Status: Resolved
Manufacturer: Soft Computer Consultants, Inc.
Manufactured In: United States
Units Affected: 2 products (189 total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.