FDA Device recall Z-2227-2021
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
- FDA Device
- Class II
- ongoing
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" by Carl Zeiss Meditec, citing due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2227-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-08 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carl Zeiss Meditec |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Reason
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Identifiers
| code_info | Model 6000 Material Number/Product Description: 266002-1173-109/SD-OCT 6000 NEW CM ENH1 Serial Numbers: 6000-10007;…Model 6000 Material Number/Product Description: 266002-1173-109/SD-OCT 6000 NEW CM ENH1 Serial Numbers: 6000-10007; 6000-10008; 6000-10010; 6000-10011; 6000-10012; 6000-10015; 6000-10016; 6000-10017; 6000-10020; 6000-10021; 6000-10022; 6000-10023; 6000-10024; 6000-10025; 6000-10026; 6000-10029; 6000-10031; 6000-10032; 6000-10034; 6000-10038; 6000-10039; 6000-10041; 6000-10043; 6000-10045; 6000-10047; 6000-10048; 6000-10049; 6000-10050; 6000-10051; 6000-10052; 6000-10053; 6000-10054; 6000-10056; 6000-10057; 6000-10058; 6000-10059; 6000-10060; 6000-10061; 6000-10062; 6000-10063; 6000-10064; 6000-10065; 6000-10066; 6000-10067; 6000-10068; 6000-10070; 6000-10071; 6000-10073; 6000-10074; 6000-10075; 6000-10076; 6000-10077; 6000-10078; 6000-10079; 6000-10080; 6000-10081; 6000-10082; 6000-10084; 6000-10085; 6000-10086; 6000-10087; 6000-10088; 6000-10089; 6000-10091; 6000-10092; 6000-10093; 6000-10095; 6000-10096; 6000-100 |
|---|
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-2227-2021%22
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