Class II — SCC Soft Computer
| Recalling firm | SCC SOFT COMPUTER |
|---|---|
| Registered facility | SCC SOFT COMPUTER (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database. |
| Product | SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0 |
| Quantity | 108 units |
| Distribution | Distribution US Nationwide and CANADA. |
| Initiated | 2014-11-26 |
| Classified | 2015-02-09 |
| Terminated | 2016-05-16 |
| Recall number | Z-1065-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SCC Soft Computer (Z-1065-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69837/
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