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.
This recall has been terminated (originally issued November 23, 2011).
- Company
- Scc Soft Computer
- Recall Initiated
- March 22, 2011
- Posted
- November 23, 2011
- Terminated
- October 29, 2012
- Recall Number
- Z-0278-2012
- Quantity
- 12
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Sold throughout US and Canada.
Lot / Code Info
Softlab 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.
Root Cause
Software change control
Action Taken
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.