FDA-Device2021-08-18Class II
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Carl Zeiss Meditec, Inc.
Hazard
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Sold states
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S.: N/A
Affected count
914 systems
Manufactured in
5160 Hacienda Dr, N/A, Dublin, CA, United States
Products
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2021Don't want to check this manually?
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