GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solution

FDA device recall Z-2563-2011 · posted 2011-06-14 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted.

Action taken

GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 3, 2011 to all affected customers. The letter describes the product, problem, and action to be taken by the customer. The letter provided the users with specific safety instructions to follow until the software was updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

14 units

Distribution

Worldwide Distribution-- USA (nationwide) including states of Georgia, New York, Ohio, Oregon, and Tennessee and countries of Canada, England, and Qatar.

Date initiated

2011-05-03

Date posted

2011-06-14

Date terminated

2011-10-04

Location

Barrington, IL