Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as

FDA device recall Z-0214-2009 · posted 2008-11-12 · Terminated

Recall details

Recalling firm

Sunquest Information Systems, Inc.

Reason for recall

While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (Cache)was not communicated or displayed in the Graphic User Interface (GUI) application so the activity continued. While this error was registered in the error log in the System U

Action taken

A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

139

Distribution

Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.

Date initiated

2008-08-01

Date posted

2008-11-12

Date terminated

2011-11-28

Location

Tucson, AZ