Atlas FDA

SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956

FDA device recall Z-0278-2012 · posted 2011-11-23 · Terminated

Recall details

Recalling firm
SCC Soft Computer
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.
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.
Root cause
Software change control
Status
Terminated
Product code
LNX
Quantity affected
12
Distribution
Sold throughout US and Canada.
Date initiated
2011-03-22
Date posted
2011-11-23
Date terminated
2012-10-29
Location
Clearwater, FL

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