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

Recall date

January 14, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0723-2022

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex