U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Calculator/data processing module, for clinical use - Product Code JQP
원인
The centricity laboratory removes free-text notes on a master panel when the user deletes the slave panel. the deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. additionally, the displayed and hl7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.G >7 to report numeric results.
조치
GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated Nov 20, 2012 to all affected customers. The letter described the product, problems and actions to be taken. The customers were instructed to follow the safety instructions and to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #86071.
Customers were instructed to contact their GE Service Representative with any questions regarding this issue. For other questions, contact GE Helpdesk:
North America; (905) 479-1249 or 1-888-778-3375; email: tgg.nahelpdesk@med.ge.com
Europe; +44 1603 877595; email: tgg.ukhelpdesk@med.ge.com
Asia Pacific; +61 3 5327 4000; email: tgg.ozhelpdesk@med.ge.com.
For questions regarding this recall call 847-277-5000.
Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
제품 설명
Centricity Laboratory Core Lab System 4.1 || The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.