CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Reason: Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

Code information: All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

Distribution pattern: 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