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

FDA device recall Z-0330-2014 · posted 2013-11-15 · Terminated

Recall details

Recalling firm

GE Healthcare It

Reason for recall

GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the ma

Action taken

GE Healtchare sent an Urgent Medical Device Correction letter dated March 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers review their workflows to determine whether this series of events could happen at their sites. Customers who self-identified this series of events as a possible workflow are recommended to contact their GE service representative for a software correction. These customers may also elect to identify master panels that may be re-routed ad hoc and then to ensure that the specimen group field is updated to NULL if currently set to blank. Customers with any questions about this issue are advised to contact their GE service representative or the GE Healthcare IT Help Desk: North America at tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-277-4468.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

7 units

Distribution

Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.

Date initiated

2013-03-12

Date posted

2013-11-15

Date terminated

2016-06-10

Location

Barrington, IL