FDA-Device2013-03-06Class II
GE Healthcare Definium 5000 / 5220493 X-Ray System
GE Healthcare, LLC
Hazard
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Sold states
Nationwide Distribution
Affected count
312 installed in US
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare Definium 5000 / 5220493 X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0703-2013Don't want to check this manually?
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