FDA-Device2014-01-01Class II
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Ziehm Imaging Inc
Hazard
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
Sold states
USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Affected count
60 devices
Manufactured in
6280 Hazeltine National Dr, Suite 100, Orlando, FL, United States
Products
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2014Don't want to check this manually?
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