🔍 RecallPedia

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Class I - Dangerous
🏥 Medical Devices Recalled: January 14, 2022 Carl Zeiss Meditec Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Carl Zeiss Meditec, Inc.
Reason for Recall:
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Product Codes/Lot Numbers:

All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0723-2022

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