Device 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.
Z-1097-2017
Product summary
- Event
- Event 76046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 189 total
- Official record key
device-enforcement:Z-1097-2017
Official wording
Reason: Software error. Potential for incorrect results
Code information: Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0
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