# FDA recall Z-0723-2022

> **Carl Zeiss Meditec, Inc.** · Class II · device recall initiated 2022-01-14.

## 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

- **Recall number:** Z-0723-2022
- **Recalling firm:** Carl Zeiss Meditec, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-14
- **Report date:** 2022-03-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0723-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0723-2022. Source: US FDA. Licensed CC0.

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