🔍 RecallPedia

CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0

Class I - Dangerous
🏥 Medical Devices Recalled: October 15, 2019 Cuattro Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Product Version: 4.4.128
  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:
Cuattro LLC
Reason for Recall:
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0

Product Codes/Lot Numbers:

Product Version: 4.4.128

Distribution:

Distributed in: US, NJ, MI, SC, NC, AR

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1934-2020