Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0074-2011

Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400 Tech Data Drive...

SCC Soft Computer / initiated 2004-11-30 / Terminated / root cause: software

SCC Soft Computer began a recall of Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Soft Query Results Reporting... on . The reason FDA records is "Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 HIS may display incorrect collection data for a procedure or test result. Clients using HBO Star RR interface to query for results on a canceled test may see...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0074-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
SCC Soft Computer
Product
Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Soft Query Results Reporting version 2.2.0.6.3 was released for General Availability on 09/11/03. Soft Query Results Reporting version 2.2.0.7.1 was released for General Availability on 01/08/04.
Product code
LNX
Reason for recall
Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 HIS may display incorrect collection data for a procedure or test result. Clients using HBO Star RR interface to query for results on a canceled test may see the previous occurrence of the test with the current date and time displayed as the collection date and time instead of the correct collection date and time sent by the SCC interf
Root cause tag
software
FDA root cause
Software design
Action
Client Notification Task Verbiage was sent through the Task Management System on December 3, 2003, identifying the software issue, the clinical impact, and corrective action. Customers were informed that the HIS may display incorrect collection data. Customers received the SQRR Service Pack with revised software, which will will not produce inaccurate information if there are no verified results. Customers were to acknowledge receipt of the task notification and indicate whether they would like the corrected software. SCC Soft Computer proprietary Task Management System is used to manage client communication. Clients use this system to request services, receive and provide software updates for any issue. Customers can contact SCC Soft Computer at 727-789-0100.
Quantity in commerce
5
Distribution
Nationwide Distribution: including states of GA, LA, and NH.
Product codes and lots
Versions 2.2.0.6.3 and 2.2.0.7.1.