Reported Aug 18, 2021 · Ongoing
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
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. · 5160 Hacienda Dr · Dublin, CA · 94568-7562
Is this the product you have?
- Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
- Lot codes and dates
- Model 6000
- Material Number/Product Description266002-1173-109/SD-OCT 6000
- NEW CM ENH1 Serial Numbers
882 of 882 codes
6000-100076000-100086000-100106000-100116000-100126000-100156000-100166000-100176000-100206000-100216000-100226000-100236000-100246000-100256000-100266000-100296000-100316000-100326000-100346000-100386000-100396000-100416000-100436000-100456000-100476000-100486000-100496000-100506000-100516000-100526000-100536000-100546000-100566000-100576000-100586000-100596000-100606000-100616000-100626000-100636000-100646000-100656000-100666000-100676000-100686000-100706000-100716000-100736000-100746000-100756000-100766000-100776000-100786000-100796000-100806000-100816000-100826000-100846000-100856000-10086
- Material Number/Product Description266002-1173-110/SD-OCT 6000
- REFURB CM ENH1 Serial Numbers
6000-100046000-100056000-100136000-100286000-100466000-100556000-100836000-101136000-101156000-101256000-101396000-101406000-101546000-101566000-102286000-102326000-102376000-102476000-102646000-102666000-103146000-103626000-104476000-104936000-105606000-107076000-107126000-107426000-107986000-109306000-110056000-113676000-11496
- Amount recalled
- 914 systems
Where it was sold
Why it was recalled
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
This product could cause temporary or reversible health problems — stop using it.
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