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
Ge healthcare is aware of a potential safety issue associated with the use of ge centricity laboratory core lab calculated results in two scenarios.
in scenario 1: calculated results greater than 6 digits plus a decimal are reported as 0 instead of too big when significant figures are not defined for the item.
in scenario 2: calculated results greater than 6 digits plus a decimal are trunc.
조치
An URGENT MEDICAL DEVICE CORRECTION letter date March 12, 2013 was sent to customers. The letter requests that customers review all calculated results to determine if either of the scenarios could occur at their site. If a customer determines that either of the scenarios proposed in the letter could occur at their site, the customer can contact their GE service representative to request or install the software update. Customers with questions can contact the GE Healthcare IT Helpdesk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com.
Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.
제품 설명
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. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. || The Centricity Laboratory System product 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 also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users