Device product
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Z-1910-2019
Product summary
- Event
- Event 82998
- Status
- Terminated
- Classification
- Class II
- Quantity
- 145 (87 US 103 OUS)
- Official record key
device-enforcement:Z-1910-2019
Official wording
Reason: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
Code information: UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9, 6.0SP9.01, CPACS 6.0 SP9.0.1, UV 6.0 SP9.0.1, UV 6.0 SP9.01.1, UV 6.0 SP9.0.1.2, UV 6.0 SP9.01.3, UV6.0 SP9.01.4, UV 6.0 SP9.01.5, UV 6.0 SP9.0.1.6, UV Version 6.0 SP5.0.4.1, UV Version 6.0 SP9, UV Version 6.0 SP9.0.0.1, UV Version 6.0 SP901, UV Version 6.0 SP9011, and UV Version 6.0 SP902
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.
Derived failure modes
-
Unknown
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.