SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. SCC Soft Computer

FDA device recall Z-0365-2011 · posted 2010-11-16 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of Stays are affected.

Action taken

Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

49

Distribution

Nationwide Distribution

Date initiated

2009-04-01

Date posted

2010-11-16

Date terminated

2013-08-07

Location

Clearwater, FL