FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec, Inc.: CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- Recall number
- Z-0723-2022
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Product
- CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- Status
- Open, Classified
- Initiated
- 2022-01-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
- 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
- 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
- Lot, serial or model codes
- All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
- 510(k) numbers
- ["K181534"]
- PMA numbers
- not on file
- Product code
- OBO
- Firm FEI
- 2918630
- Firm city
- Dublin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28