Recall Z-2227-2021 ยท OBO Tomography, Optical Coherence
Carl Zeiss Meditec, Inc.
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
| Date | Jul 8, 2021 |
| Status | Open, Classified |
| Reason | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device. |
| Root cause | No Marketing Application |
| Action | On 07/08/2021 the firm sent an "Medical Device Recall" Notification Letter via UPS informing customers that it commercialized in the U.S. a device without receiving a substantial equivalence clearance [510(k)]. The Recalling Firm is informing and instructing its customers, that while it is working on submitting and received a 510(k) clearance, the affected system may continued to be used as normal. The Recalling Firm has placed a ship hold on all distribution for the U.S. market, but will continue to provide product support for current customers. Customers are also instructed to complete an |
| Quantity | 914 systems |
| Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181534 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc., Feb 15, 2019 |