FDA Device recall Z-1098-2017
Softbank software Product Usage: Decision support software for transfusion service
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Softbank software Product Usage: Decision support software for transfusion service by Soft Computer Consultants, citing software error. Potential for incorrect results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1098-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-06 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Soft Computer Consultants |
| Distribution | US |
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
Software error. Potential for incorrect results
Identifiers
| code_info | Version: 35.5.2.0, 25.5.3.0, 25.5.3.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.