Z-1097-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- October 6, 2016
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189 total
Product Description
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.
Reason for Recall
Software error. Potential for incorrect results
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
Code Information
Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0