Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
FDA Recall Z-2227-2021 · Posted None
Recalling FirmCarl Zeiss Meditec, Inc.
Recall StatusOpen, Classified
Product CodeOBO
Date Initiated2021-07-08
Product Quantity914 systems
Reason for Recall
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Firm 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 and return the Acknowledgement and Receipt Form via email at [email protected] or via Fax at 925-448-3880.
For any questions, contact Customer Service at 877-486-7473.
Root Cause
No Marketing Application
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.