Carl Zeiss Meditec, Inc. CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Brand
Carl Zeiss Meditec, Inc.
Lot Codes / Batch Numbers
All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Products Sold
All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Carl Zeiss Meditec, Inc. is recalling CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex due to Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026