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U.S. Department of Health and Human Services

Class 2 Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1

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  Class 2 Device Recall Soft Query Results Reporting Versions 2.2.0.6.3 and 2.2.0.7.1 see related information
Date Initiated by Firm November 30, 2004
Date Posted October 18, 2010
Recall Status1 Terminated 3 on October 19, 2010
Recall Number Z-0074-2011
Recall Event ID 56274
Product Classification Medical computers and software - Product Code LNX
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.
Code Information Versions 2.2.0.6.3 and 2.2.0.7.1. 
Recalling Firm/
Manufacturer
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer 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
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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