FDA Recall
Terminated
SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
Recall: Z-0278-2012
·
Initiated March 22, 2011
Recall
- Recall Number
- Z-0278-2012
- Event Number
- 60430
- Firm
- SCC Soft Computer
- FEI Number
- 1000307651
- Product Code
- LNX
- Status
- Terminated
- Root Cause
- Software change control
- Initiated
- March 22, 2011
- Posted
- November 23, 2011
- Terminated
- October 29, 2012
- Address
- 5400 Tech Data Drive, Clearwater, FL, 33760
Description
SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
Reason
Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur, this function has the potential to cause faulty writing to the database.
Action
Clients were notified through SCC Soft Computer's proprietary Task Management System On 03/22/201. All clients have received a hot fix that corrected the issue or made the hosparam change that prevents the issue.
Distribution
Sold throughout US and Canada.
Quantity
12