Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CIRRUS HD-OCT Recalled by Carl Zeiss Meditec, Inc. Due to Optic nerve head angiography scan to be turned...

Date: January 14, 2022
Company: Carl Zeiss Meditec, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Carl Zeiss Meditec, Inc. directly.

Affected Products

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Quantity: 1,272 devices

Why Was This Recalled?

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Carl Zeiss Meditec, Inc.

Carl Zeiss Meditec, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report