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GE Medical Systems, LLC recalls Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imagin
Recalled December 28, 2022 · FDA recall Z-0722-2023 · GE Medical Systems
Hazard
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. · FDA Class II
Units
236 units
Sold at
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.
Description
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.
Product
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →