Device product
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Z-0721-2023
Product summary
- Event
- Event 91159
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0721-2023
Official wording
Reason: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
Code information: Installed Product ID: YP3150-Centricity Universal Viewer-01639018
Distribution pattern: Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.