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U.S. Department of Health and Human Services

Class 2 Device Recall SoftWeb Version 4.0.4.10.1

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  Class 2 Device Recall SoftWeb Version 4.0.4.10.1 see related information
Date Initiated by Firm June 08, 2006
Date Posted October 20, 2010
Recall Status1 Terminated 3 on November 03, 2010
Recall Number Z-0099-2011
Recall Event ID 56282
Product Classification Medical computers and software - Product Code LNX
Product SoftWeb version 4.0.4.10.1.
SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.

Manufacture Date: 05/16/2006.
Code Information version 4.0.4.10.1.
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information Contact
727-789-0100
Manufacturer Reason
for Recall		 If a case number is re-used in SoftWeb with SoftPath, the SoftPath case is linked to the original MRN in SoftWeb. This causes SoftPath cases being linked to the wrong patient in SoftWeb. Incorrect results on the patient with original MRN and no results on the patient with the second MRN (and the reused case number) are displayed in SoftWeb Results Query. SCC Soft Computer issued a Correction for
FDA Determined
Cause 2		 Software design
Action SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System on June 8, 2006. SCC recommended SoftPath/SoftWeb users NOT re-use SoftPath case numbers when cases are cancelled. The generic option setting "Specimen Registration - Standard Settings - Minimum Time to Reactivate Case Number" should be set to "0" so the user is not prompted to reuse the same case number. Client was asked to acknowledge receipt of the task and grant permission to load the required software correction.
Quantity in Commerce 1
Distribution Nationwide Distribution: 1 hospital in Alaska.
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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