Z-1098-2017Class II

Softbank software

Name: Z-1098-2017 Softbank software
Creator: Soft Computer Consultants, Inc.
Published: 2016-10-06
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2016-10-06 / Terminated / root cause: software

FDA source

Soft Computer Consultants, Inc. began a recall of Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory... on 2016-10-06. FDA classified it as Class II and gives the reason as "Software error. Potential for incorrect results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1098-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-06
Posted: 2017-01-26
Terminated: 2019-08-21
Recalling firm: SCC Soft Computer
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.
Product code: NSX
Reason for recall: Software error. Potential for incorrect results
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: Version: 35.5.2.0, 25.5.3.0, 25.5.3.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1097-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26
Z-1098-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-26

Product code NSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)