Recall Z-0102-2011 ยท LNX
SCC Soft Computer
SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
| Date | Oct 20, 2010 (initiated Jan 26, 2009) |
| Status | Terminated |
| Reason | For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However, the patient final report, HIS resulting and Query display are all correct. All affected clients have been provided corrected software.. |
| Root cause | Software design |
| Action | SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System on January 26, 2009. SCC issued a software upgrade with corrective patch electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software. SCC will contact each client to coordinate the running of the utility and the loading and validation of the correct patch. |
| Quantity | 52 |
| Distribution | Worldwide Distribution: Throughout USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.