FDAFDA · Food and drugs·Recall number Z-1097-2017
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.
Published February 1, 2017 · Recall initiated: October 6, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software error. Potential for incorrect results
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Soft Computer Consultants, Inc.
- Distributor
- Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
- Lot
- Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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