Carl Zeiss Meditec, Inc. Recall 89524
Description: CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Carl Zeiss Meditec, Inc. Recall 89524 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0723-2022 |
| Event ID | 89524 |
| Event Description | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex |
| Product Type | 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 |
| Quantity | 1,272 devices |
| Recall Reason | Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. |
| Device Classification | 20220316 |
| Device 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 |
| Center Classification Date | 20220304 |
| Recall Initiation Date | 20220114 |
| Recalling Firm | Carl Zeiss Meditec, Inc. |
| Initial Notification | Letter |
| Similar To |