FDA-Device2017-02-01Class II

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.

Soft Computer Consultants, Inc.
Hazard

Software error. Potential for incorrect results

Sold states
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
Affected count
189 total
Manufactured in
5400 Tech Data Dr, N/A, Clearwater, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1098-2017

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