Recall Z-0723-2022 ยท OBO Tomography, Optical Coherence
Carl Zeiss Meditec, Inc.
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
| Date | Jan 14, 2022 |
| Status | Open, Classified |
| 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 Acknowle |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181534 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc., Feb 15, 2019 |