Carl Zeiss Meditec, Inc. Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

Recommended Action

Per FDA guidance

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 and return the Acknowledgement and Receipt Form via email at USFCA.meditec.us@zeiss.com or via Fax at 925-448-3880. For any questions, contact Customer Service at 877-486-7473.

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR