Company: GE Healthcare IT
Date of Enforcement Report 2/23/2011
Class ll:
PRODUCT
GE Centricity Laboratory software; The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results. Recall # Z-1245-2011.
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare IT, Barrington, IL, by letters dated December 12, 2010.
Manufacturer: Triple G Systems Group, Inc., Markham Ontario, Canada. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide and Internationally
