Reported Mar 16, 2022 · Ongoing
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Carl Zeiss Meditec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec, Inc. · 5300 Central Parkway · Dublin, CA · 94568
Is this the product you have?
- CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- Lot codes and dates
- All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
- Amount recalled
- 1,272 devices
Where it was sold
Why it was recalled
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
This product could cause temporary or reversible health problems — stop using it.
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