Carl Zeiss Meditec, Inc. recalls CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Recalled March 16, 2022 · FDA recall Z-0723-2022 · Carl Zeiss Meditec

Hazard

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. · FDA Class II

Units

1,272 devices

Sold at

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

Description

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

Product

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Manufacturer(s)

Carl Zeiss Meditec, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →