Device product
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.
Z-2469-2015
Product summary
- Firm
- GE Healthcare
- Event
- Event 71964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82 systems
- Official record key
device-enforcement:Z-2469-2015
Official wording
Reason: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Code information: Model Number: Centricity PACS-IW with Universal Viewer Version 5.0 through 5.0 SP7 Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present
Distribution pattern: Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX; France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, Poland, Russia, South Africa, Saudi Arabia, Switzerland, Turkey, UAE and Uruguay.
Derived failure modes
-
Unknown
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.