FDA recall Z-0723-2022

Carl Zeiss Meditec, Inc. · Class II · device

Product

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Reason for recall

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-01-14
Report date: 2022-03-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2022