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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2022%22
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