FDA-Device2016-08-31Class II
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Ziehm Imaging Inc
Hazard
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Sold states
US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
Affected count
2 devices
Manufactured in
6280 Hazeltine National Dr Ste 100, Orlando, FL, United States
Products
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2644-2016Don't want to check this manually?
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