PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 1, 2017 Initiated: October 6, 2016 #Z-1097-2017

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

Details

Units Affected
189 total
Distribution
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
Location
Clearwater, FL

Frequently Asked Questions

What product 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.. Recalled by Soft Computer Consultants, Inc.. Units affected: 189 total.
Why was this product recalled?
Software error. Potential for incorrect results
Which agency issued this recall?
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1097-2017.