FDA Device recall Z-0723-2022
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex by Carl Zeiss Meditec, citing optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0723-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-14 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carl Zeiss Meditec |
| Distribution | US |
Product
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Reason
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Identifiers
| code_info | All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Carl Zeiss Meditec
- Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
FDA Device · Class II · 2021-08-18 · Carl Zeiss Meditec - The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high res…
FDA Device · Class II · 2020-01-08 · Carl Zeiss Meditec - VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser…
FDA Device · Class II · 2019-12-25 · Carl Zeiss Meditec - Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Z…
FDA Device · Class II · 2013-11-27 · Carl Zeiss Meditec - Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zei…
FDA Device · Class II · 2013-11-27 · Carl Zeiss Meditec
All Carl Zeiss Meditec recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.