Device 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.
Z-1098-2017
Product summary
- Event
- Event 76046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 189 total
- Official record key
device-enforcement:Z-1098-2017
Official wording
Reason: Software error. Potential for incorrect results
Code information: Version: 35.5.2.0, 25.5.3.0, 25.5.3.1
Distribution pattern: 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
Derived failure modes
-
Device software or design
Software error. Potential for incorrect