Recall Z-0365-2011 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: 4.0.1.0 - 08/06/04, 4.0.1.4 - 10/18/04, 4.0.1.5 - 01/18/04, 4.0.1.6 - 12/15/04, 4.0.1.7 - 01/10/05, 4.0.1.8 - 03/29/05, 4.0.1.9 - 05/06/05, 4.0.1.13 - 01/25/06, 4.0.1.14 - 03/26/07
| Date | Nov 16, 2010 (initiated Apr 1, 2009) |
| Status | Terminated |
| Reason | Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of Stays are affected. |
| Root cause | Software design |
| Action | Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software. |
| Quantity | 49 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.