The Centricity Laboratory System is intended to be an information system designed to support the clinical and administra

FDA device recall Z-1585-2013 · posted 2013-06-24 · Terminated

Recall details

Recalling firm

GE Healthcare It

Reason for recall

If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is available. Please contact your GE service representative to request or install this update. Please contact your GE Service Representative with any question regarding this issue. For other questions please contact GE Helpdesk. Help Desk: North America: 1-888-778-3375 Help Desk: Europe: + 44 1603 877595 Help Desk: Asia Pacific + 61 3 5327 4000

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

9 Units

Distribution

Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England

Date initiated

2012-11-20

Date posted

2013-06-24

Date terminated

2016-06-10

Location

Barrington, IL