SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.

FDA device recall Z-0099-2011 · posted 2010-10-20 · Terminated

Recall details

Recalling firm

SCC Soft Computer

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

1

Distribution

Nationwide Distribution: 1 hospital in Alaska.

Date initiated

2006-06-08

Date posted

2010-10-20

Date terminated

2010-11-03

Location

Clearwater, FL