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.
FDA Recall Z-0278-2012 · Posted 2011-11-23
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Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2011-03-22
Date Terminated2012-10-29
Product Quantity12
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.
Firm 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.
Root Cause
Software change control
Distribution Pattern
Sold throughout US and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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