Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centric

FDA device recall Z-1397-2009 · posted 2009-05-15 · Terminated

Recall details

Recalling firm

GE Healthcare Integrated IT Solutions

Reason for recall

A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.

Action taken

GE Healthcare notified their Centricity TriWin Laboratory customer via letter dated 11/17/08 of the software anomalies resulting in patient safety issues involving the patient information incorrectly being linked to a wrong report, and when viewing results in Patient Viewer, and a coagulation result is outside of a linearity limit, then all of the results following the out of linearity result will show the same result as the first flagged result. The user was informed that a software patch has been prepared to resolve the issues and will be installed on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 905-305-0046 to schedule the software upgrade.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

26 units

Distribution

Worldwide Distribution -- USA and country of Canada.

Date initiated

2008-11-17

Date posted

2009-05-15

Date terminated

2010-09-11

Location

Barrington, IL