SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. SCC Soft Computer 5400 Tech Data Drive Clearwater,

FDA device recall Z-0362-2011 · posted 2010-11-15 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient history reports using Patient>Reports>Batch Reports>History Report option in SoftBank with SoftReports activated for patient reports, when the report is generated for more than one patient ALL of the results for the qualif

Action taken

SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments. If you have any questions, contact (727) 789-0100.

Root cause

Software design

Status

Terminated

Product code

MMH

Quantity affected

30

Distribution

Worldwide distribution: U.S. and country of Canada.

Date initiated

2010-06-22

Date posted

2010-11-15

Date terminated

2012-09-05

Location

Clearwater, FL