CIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation
Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries, illnesses, or deaths. The recall addresses a regulatory compliance issue—the optic nerve head angiography feature was distributed without pre-market clearance. This classification is Moderate severity, reflecting a regulatory/compliance violation without reported patient harm.
Plain-English summary
Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 AngioPlex and 6000 AngioPlex devices. The optic nerve head (ONH) angiography scan feature was distributed without FDA pre-market clearance.
Approximately 1,272 devices running software versions 11.5, 11.5.1, and 11.5.2 are affected. These devices have been distributed nationwide across all U.S. states, Puerto Rico, and the District of Columbia.
Users of affected devices should contact Carl Zeiss Meditec for instructions to disable the optic nerve head angiography 4.5x4.5mm scan feature.
The recalled product
- Product
- CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Hazard
- Affected units
- 1,272
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All instrument serial numbers running running software versions 11.5
- 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Distribution
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