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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity Laboratory

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  Class 2 Device Recall GE Centricity Laboratory see related information
Date Initiated by Firm December 03, 2010
Date Posted February 15, 2011
Recall Status1 Terminated 3 on July 15, 2011
Recall Number Z-1245-2011
Recall Event ID 57379
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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.
Code Information Software versions 3.x and 4.x
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 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 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, England, Hong Kong, India, Malaysia, New Zealand, Qatar, Scotland and Singapore.
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.
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