SoftID.NET versions 2.0.0.6 - 2.0.0.19. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftID.NET is to be

FDA device recall Z-0360-2011 · posted 2010-11-15 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

SCC Soft Computer issued a Correction for SoftID.NET versions 2.0.0.6 - 2.0.0.19. When using the Cancel functionality, if the collection list refreshes during the transaction and changes the position of the patient on the list, the wrong patient order can be cancelled. All affected clients have been notified.

Action taken

SCC Soft Computer notified Customers on August 28, 2009, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated August 17, 2009. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; document a request to load the software, if they wish to receive the correction; document that the Alternative Working Solution will be used by the customers facility until the correction has been taken live. If you have any questions, contact (727) 789-0100.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

41

Distribution

Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.

Date initiated

2009-08-28

Date posted

2010-11-15

Date terminated

2011-11-16

Location

Clearwater, FL