The Recall Desk
ModerateFDA (Devices)·Z-0723-2022·Announced 2022-03-16

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.

What this means for you

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.
Category
Medical Device — Diagnostic Imaging / Ophthalmology
Hazard
  • uncleared-feature

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

Distributed nationwide across the United States.

Related recalls

Same category