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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI Releases 3.17 through 4.1.0.

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 Class 2 Device Recall SoftPath GUI Releases 3.17 through 4.1.0.see related information
Date Initiated by FirmMarch 28, 2007
Date PostedOctober 15, 2010
Recall Status1 Terminated 3 on October 19, 2010
Recall NumberZ-0067-2011
Recall Event ID 56275
Product Classification Medical computers and software - Product Code LNX
ProductSoftPath GUI Releases 3.17 through 4.1.0. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: Version 3.17.5 10/14/2003. Version 3.17.6 03/28/2003. Version 3.17.7 07/02/2003. Version 3.17.8 03/03/2004. Version 4.1.0 07/03/2003. Version 4.1.1 10/03/2003. Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.
Code Information Versions 3.17.5, 3.17.6, 3.17.7, 3.17.8, 4.1.0, and 4.1.1.
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 SoftPath GUI Releases 3.17 and 4.1 in March 2007 for clients with high volume output of final reports who use the Batch Print for Final Reports in the Scheduler, there is a potential for some reports not printing. This issue was corrected for the one affected user in October 2003.
FDA Determined
Cause 2		Software design
ActionSCC Soft Computer sent a SAFETY NOTIFICATION TASK VERBIAGE dated January 5, 2004, to one client. The Notice identified the product, the problem, and the action to be taken by the client. SCC recommended the client set the Search Date Range to a small enough range to assure that the number of cases scanned during the job would be less than 10,000. The client was asked to acknowledge receipt of the task and to indicate if the Workflow or functionality was used/not used and Agree to use the alternative working solution. For any questions regarding this recall call (727) 780-0100, ext. 4235.
Quantity in Commerce84
DistributionNationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV
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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