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

FDA device recall Z-0865-2014 · posted 2014-01-29 · Terminated

Recall details

Recalling firm

GE Healthcare It

Reason for recall

GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. In Scenario 1: Calculated results greater than 6 digits plus a decimal are reported as 0 instead of TOO BIG when significant figures are not defined for the item. In Scenario 2: Calculated results greater than 6 digits plus a decimal are trunc

Action taken

An URGENT MEDICAL DEVICE CORRECTION letter date March 12, 2013 was sent to customers. The letter requests that customers review all calculated results to determine if either of the scenarios could occur at their site. If a customer determines that either of the scenarios proposed in the letter could occur at their site, the customer can contact their GE service representative to request or install the software update. Customers with questions can contact the GE Healthcare IT Helpdesk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

7 units

Distribution

Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.

Date initiated

2012-11-20

Date posted

2014-01-29

Date terminated

2016-05-16

Location

Barrington, IL