Z-1097-2017 Class II Terminated
FDA device recall Z-1097-2017 was initiated by Soft Computer Consultants, Inc. on October 6, 2016 and is designated Class II. Reason for recall: Software error. Potential for incorrect results The recall status is terminated (terminated August 21, 2019). Affected quantity: 189 total.
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