Device product
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
Z-0865-2014
Product summary
- Firm
- GE Healthcare It
- Event
- Event 64795
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7 units
- Official record key
device-enforcement:Z-0865-2014
Official wording
Reason: 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
Code information: Software Versions: 3.3, 4.0, 4.1
Distribution pattern: Worldwide Distribution - US (Nationwide) to states of: MN, GA, and CA; and International to: England.
Derived failure modes
-
Unknown
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