🔍 RecallPedia

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

Class I - Dangerous
🏥 Medical Devices Recalled: January 3, 2024 FUJIFILM Healthcare Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
  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:
FUJIFILM Healthcare Americas Corporation
Reason for Recall:
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

Product Codes/Lot Numbers:

UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1172-2024

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