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Terminated

SoftPath 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.

FDA Recall Z-0067-2011 · Posted 2010-10-15

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2007-03-28
Date Terminated2010-10-19
Product Quantity84

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.

Firm Action

SCC 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.

Root Cause

Software design

Distribution Pattern

Nationwide - 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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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