Food, drugs, devices › Soft Computer Consultants, Inc.
Device recall: SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare
Soft Computer Consultants, Inc. (Clearwater, FL) initiated this device recall on 6 Oct 2016; FDA lists 2 product records under event 76046, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 21 Aug 2019. Initiation: voluntary: firm initiated. Soft Computer Consultants, Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Soft Computer Consultants, Inc., Clearwater, FL.
Reason for recall
"Software error. Potential for incorrect results"
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1097-2017 | 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… | 189 total | Class II | Terminated | 1 Feb 2017 |
| Z-1098-2017 | 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. | 189 total | Class II | Terminated | 1 Feb 2017 |
Context
Other enforcement events for Soft Computer Consultants, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Mar 2021 | SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a cl | Device | Class II | 1 |
| 31 Mar 2021 | SoftCytogenetics | Device | Class II | 1 |
| 31 May 2017 | SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, | Device | Class II | 1 |
All 4 events for Soft Computer Consultants, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Software error. Potential for incorrect results"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.