FDA Medical Device Recalls (openFDA)
Soft Computer Consultants, Inc.: 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 number
- Z-1098-2017
- Recalling firm
- Soft Computer Consultants, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-10-06
- Posted
- not on file
- Terminated
- 2019-08-21
- Reason
- Software error. Potential for incorrect results
- Root cause
- Software design (manufacturing process)
- 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).
- Quantity
- 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
- Lot, serial or model codes
- Version: 35.5.2.0, 25.5.3.0, 25.5.3.1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSX
- Firm FEI
- 1000307651
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28