SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to b

FDA device recall Z-0362-2012 · posted 2011-12-02 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

On 10/25/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. When SoftReports Designer opened a layout, the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page. All affected clients were notified on the issue on

Action taken

SCC Soft Computer sent a "Correction Notification" letter dated October 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The hot fixes that were previously loaded which introduced this issue were corrected and delivered to all affected customers as a mandatory correction in hot fixes 1.7199.8 and 1.7200.8 and higher.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

5

Distribution

Nationwide Distribution.

Date initiated

2011-10-25

Date posted

2011-12-02

Date terminated

2012-03-16

Location

Clearwater, FL