Z-0723-2022Class II

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Name: Z-0723-2022 CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Creator: Carl Zeiss Meditec, Inc.
Published: 2022-01-14
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2022-01-14 / Open, Classified

FDA source

Carl Zeiss Meditec, Inc. began a recall of CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex on 2022-01-14. FDA classified it as Class II and gives the reason as "Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0723-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-14
Posted: 2022-03-04
Recalling firm: Carl Zeiss Meditec Inc
Product: CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Product code: OBO Tomography, Optical Coherence
Reason for recall: Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
FDA root cause: No Marketing Application
Action: On 01/14/22, recall notices were mailed to customers who were asked to do the following: 1. Until further notice, please discontinue the acquisition of the ONH Angiography 4.5x4.5mm Scan. 2. Using the provided software kit(s), install software version 11.5.3 on all affected instruments. You will be receiving one software kit per affected instrument according to our records. An excerpt of the IFU has been included Section 4.7 Update Instrument Software, these instructions apply to all models. Refer to the IFU Section 4 for the full installation instructions. 3. Complete and return the Acknowledgement Form per the instructions in the attachment. In case you no longer have the device, we ask that you inform the recalling firm and forward this letter to the new owner. Customers with additional questions were encouraged to contact customer service at 1-800-341-6968 (select option 1, 1).
Quantity in commerce: 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
Product codes and lots: All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0723-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-04

Product code OBO

K181534Class IICirrus Hd-OctCarl Zeiss Meditec, Inc. / cleared 2019-02-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)