🔍 RecallPedia

CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Class I - Dangerous
🏥 Medical Devices Recalled: October 30, 2014 Carestream Health Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
  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:
Carestream Health, Inc.
Reason for Recall:
Reduced mammographic image quality when attempting to print true size multi-format images
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Product Codes/Lot Numbers:

Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031

Distribution:

Distributed in: US, NY, OH, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0820-2015

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