Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. 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.

FDA Recall Z-1245-2011 · Posted 2011-02-15

Recalling FirmGe Healthcare It
Recall StatusTerminated
Product CodeJQP
Date Initiated2010-12-03
Date Terminated2011-07-15
Product Quantity26 units

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.

Firm Action

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

Distribution Pattern

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, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑