GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory i

FDA device recall Z-1245-2011 · posted 2011-02-15 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

The GE Centricity Laboratory System Software has safety issues with the "Telephone List" function, the "Anatomic Pathology" application, and the Instrument Interface IO module that may impact patient safety.

Action taken

GE Healthcare, sent "Urgent Medical Device Correction" letters dated December 12, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the product, the problem, and the action to be taken by the customer. The letters 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

26 units

Distribution

Worldwide Distribution -- USA, including AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, NC, NH, NJ, NY, OR, TN, VA, and WI, , and internationally to the countries of Australia, Englan

Date initiated

2010-12-03

Date posted

2011-02-15

Date terminated

2011-07-15

Location

Barrington, IL