Class 2 Device Recall GE Centricity Laboratory Instrument Interface Data Innovations Instrument Manager Software

• Date Initiated by Firm: May 03, 2011
• Date Posted: June 14, 2011
• Recall Status: Terminated on October 04, 2011
• Recall Number: Z-2563-2011
• Recall Event ID: 58676
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010. The Centricity Laboratory is designed 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.
• Code Information: Versions 3.3, 4.0 and 4.1
• FEI Number: 3004526608
• Recalling Firm/ Manufacturer: Ge Healthcare It; 540 W Northwest Hwy; Barrington IL 60010-3051
• For Additional Information Contact: GE Help Desk ; 888-778-3375
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 14 units
• Distribution: Worldwide Distribution-- USA (nationwide) including states of Georgia, New York, Ohio, Oregon, and Tennessee and countries of Canada, England, and Qatar.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.