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U.S. Department of Health and Human Services

Class 2 Device Recall Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1,

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  Class 2 Device Recall Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, see related information
Date Initiated by Firm October 05, 2007
Date Posted October 15, 2010
Recall Status1 Terminated 3 on October 19, 2010
Recall Number Z-0069-2011
Recall Event ID 56278
Product Classification Medical computers and software - Product Code LNX
Product Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.

SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

Manufacture Dates:
4.0.2.38.1 06/15/07
4.02.39.2 06/29/07,
4.02.40.1 07/19/07,
4.02.41.1 08/20/07.

The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

Code Information Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. 
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer Reason
for Recall		 SCC Soft Computer, Clearwater, FL issued a Correction for Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.0.2.40.1, and 4.0.2.41.1 on 10/05/2007. A software anomaly in the result reporting interface caused result comments entered after an empty line not to be sent to the HIS system. This included interpretative comments, results, and normal range c
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer sent a RISK-TO-HEALTH NOTIFICATION TASK VERBIAGE dated October 5, 2007, through their Task Management System to all affected clients on October 17, 2007. The notice identified the product, the problem and the action clients should take to correct the problem. Clients were to acknowledge receipt of the task notice and to identify if the Workflow or functionality is not used and if they Agree to use alternative working solutions. Each client was asked to grant permission to load the required software to correct the issue. For any questions regarding this recall call (727) 789-0100.
Quantity in Commerce 35
Distribution Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada
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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