Carl Zeiss Meditec recalls CIRRUS HD-OCT models 5000 AngioPlex and 6000 AngioPlex with unapproved optic nerve head angiography scans. Affected units have specific software versions and serial numbers.
“Carl Zeiss Meditec CIRRUS HD-OCT Models 5000/6000: Unapproved Angiography Scan Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61263-carl-zeiss-meditec-cirrus-hd-oct-models-5000-6000-unapproved. Based on FDA recall #Z-0723-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2022%22&limit=1).
The FDA announced on Jan. 14, 2022, that Carl Zeiss Meditec, Inc. is recalling CIRRUS HD-OCT Models 5000 AngioPlex and 6000 AngioPlex devices due to distribution without pre-market clearance. The agency classified the recall as Class II.
How to tell if you have it
Brand: Carl Zeiss Meditec
Product: CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Software versions: 11.5, 11.5.1 and 11.5.2 with ONH Angiography 4.5x4.5mm Scan
Units affected: 1,272 devices
The hazard
The recall addresses the optic nerve head angiography scan feature being distributed without pre-market clearance. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Carl Zeiss Meditec, Inc. has issued three other recalls since Oct. 16, 2018. On July 8, 2021, the company recalled Cirrus HD-OCT Model 6000 due to lack of pre-market clearance. Other recent recalls of similar products include Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK (Feb. 25, 2026) and Philips Brilliance CT 64 Medical Scanner (Aug. 7, 2026).
How to tell if you have this one
Check if your CIRRUS HD-OCT has serial numbers with software versions 11.5, 11.5.1, or 11.5.2 and the ONH Angiography 4.5x4.5mm Scan feature.
Brand
Carl Zeiss Meditec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device's software version is 11.5, 11.5.1, or 11.5.2.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0723-2022 (January 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0723-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.