ClearanceBrief
Recall Z-0278-2012 ยท LNX

SCC Soft Computer

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.

DateNov 23, 2011 (initiated Mar 22, 2011)
StatusTerminated
ReasonPotential 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.
Root causeSoftware change control
ActionClients 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.
Quantity12
DistributionSold throughout US and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.