Data Foundry

Medical device recalls 2017

Softbank software Product Usage: Decision support software for… — Class II medical device recall Z-1098-2017

Terminated recall by Soft Computer Consultants, Inc., reported 2017-02-01, distributed nationwide. Software error. Potential for incorrect results

Recall numberZ-1098-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSoft Computer Consultants, Inc., Clearwater, FL, United States
Recall initiated2016-10-06
Classified2017-01-26
Reported by FDA2017-02-01
Terminated2019-08-21
DistributedNationwide (US)
Countries outside the USCA, JM
Quantity189 total
Reason classessoftware

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.

Reason for recall

Software error. Potential for incorrect results

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1098-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.