FDA-Device2022-03-16Class II
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Carl Zeiss Meditec, Inc.
Hazard
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Sold states
U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI
Affected count
1,272 devices
Manufactured in
5300 Central Parkway, N/A, Dublin, CA, United States
Products
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2022Don't want to check this manually?
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