CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
FDA Recall Z-0723-2022 · Posted None
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Recalling FirmCarl Zeiss Meditec, Inc.
Recall StatusOpen, Classified
Product CodeOBO
Date Initiated2022-01-14
Product Quantity1,272 devices
Reason for Recall
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Firm 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 Acknowledgement Form per the instructions in the attachment.
In case you no longer have the device, we ask that you inform the recalling firm and forward this letter to the new owner.
Customers with additional questions were encouraged to contact customer service at 1-800-341-6968 (select option 1, 1).
Root Cause
No Marketing Application
Distribution Pattern
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
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.
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