FDA Recall Terminated

Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

Recall: Z-1098-2017 · Initiated October 6, 2016

Recall

Recall Number
Z-1098-2017
Event Number
76046
Firm
Soft Computer Consultants, Inc.
FEI Number
1000307651
Product Code
NSX
Status
Terminated
Root Cause
Software design (manufacturing process)
Initiated
October 6, 2016
Terminated
August 21, 2019
Address
5400 Tech Data Dr, Clearwater, FL, 33760-3116

Description

Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

Reason

Software error. Potential for incorrect results

Action

Consignees were sent a recall notification, dated 10/06/2016, providing instructions for software correction. The firm indicates that the issue will be resolved with a mandatory hot fix. Hot fix will be released when its effectiveness is confirmed. Consignees are instructed to acknowledge receipt of the recall notification and grant permission for the recalling firm to load the hot fix when available. The firm can be contacted by calling Technical Support at 1-800-763-8522. Until the hot fix is available, consignees can still operate the software by exiting (Esc-Quit) the Test Verify option after each save changes (F12-Accept).

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

Quantity

189 total