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

FDA device recall Z-0620-2014 · posted 2014-01-02 · Terminated

Recall details

Recalling firm

GE Healthcare It

Reason for recall

GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured).

Action taken

GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers. The letter notified customers of the problem, suggested that customers experiencing this problem should retransmit the result from the instrument once the order exists in iNET and verify that the item level free-text is present in iNET, and to contact their GE service representative to request or install the updated software. Customers with additional questions can contact the GE Healthcare IT Help Desk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-589-8496.

Root cause

Device Design

Status

Terminated

Product code

JQP

Quantity affected

5 units

Distribution

Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.

Date initiated

2013-03-12

Date posted

2014-01-02

Date terminated

2016-06-10

Location

Barrington, IL