Soft Computer Consultants, Inc. recalls SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare…

Recall date

October 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1097-2017

FDA classification

Class II

Brand / firm

Soft Computer Consultants, Inc.

Sold / distributed

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

Why it was recalled

Software error. Potential for incorrect results

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.