FDA-Device2022-12-28Class II
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
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.
Sold states
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.
Affected count
236 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2023More GE Medical Systems, LLC recalls
- FDA-Device2026-06-24GE Giraffe OmniBed infant bed recalled for detachable fastener hazard
- FDA-Device2026-06-24GE Giraffe OmniBed infant incubator recalled for loose fastener risk
- FDA-Device2026-06-24GE Giraffe OmniBed Carestation recalled for loose fastener risk in infant incubator
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS Pulse X-ray system recalled for electrical shock risk to service personnel
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