SCC Soft Computer Softbank II software Product Usage: Supports single… — Class II medical device recall Z-1097-2017
Terminated recall by Soft Computer Consultants, Inc., reported 2017-02-01, distributed nationwide. Software error. Potential for incorrect results
| Recall number | Z-1097-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Soft Computer Consultants, Inc., Clearwater, FL, United States |
| Recall initiated | 2016-10-06 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2019-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JM |
| Quantity | 189 total |
| Reason classes | software |
Product
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
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-1097-2017. 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.