Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Reported: December 28, 2022 Initiated: October 28, 2022 #Z-0722-2023
Product Description
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Reason for Recall
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.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- 236 units
- Distribution
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.. Recalled by GE Medical Systems, LLC. Units affected: 236 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0722-2023.
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