SoftPath GUI Releases 3.17 through 4.1.0. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distr

FDA device recall Z-0067-2011 · posted 2010-10-15 · Terminated

Recall details

Recalling firm

SCC Soft Computer

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.

Action taken

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

Status

Terminated

Product code

LNX

Quantity affected

84

Distribution

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

Date initiated

2007-03-28

Date posted

2010-10-15

Date terminated

2010-10-19

Location

Clearwater, FL