FDAFDA · Food and drugs·Recall number Z-1098-2017
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.
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: 35.5.2.0, 25.5.3.0, 25.5.3.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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