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U.S. Department of Health and Human Services

Class 2 Device Recall CIRRUS HDOCT

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 Class 2 Device Recall CIRRUS HDOCTsee related information
Date Initiated by FirmJanuary 14, 2022
Create DateMarch 04, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0723-2022
Recall Event ID 89524
510(K)NumberK181534 
Product Classification Tomography, optical coherence - Product Code OBO
ProductCIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Code Information All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
FEI Number 2918630
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5300 Central Parkway
Dublin CA 94568
For Additional Information Contact
925-557-4100
Manufacturer Reason
for Recall		Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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).
Quantity in Commerce1,272 devices
DistributionU.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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OBO
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