Class II — Carl Zeiss Meditec, Inc.
| Recalling firm | Carl Zeiss Meditec AG (Jena) |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 1,272 devices |
| 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 |
| Initiated | 2022-01-14 |
| Classified | 2022-03-04 |
| Recall number | Z-0723-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carl Zeiss Meditec, Inc. (Z-0723-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89524/
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