🔍 RecallPedia

Synapse PACS - Version 7.1.000

Class I - Dangerous
🏥 Medical Devices Recalled: January 10, 2024 FUJIFILM Healthcare Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Software Version: 7.1.000; UDI: (01)854904006008(10)0701000
  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:
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Synapse PACS - Version 7.1.000

Product Codes/Lot Numbers:

Software Version: 7.1.000; UDI: (01)854904006008(10)0701000

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1268-2024

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