🔍 RecallPedia

Synaptive ImageDrive Clinical

Class I - Dangerous
🏥 Medical Devices Recalled: February 26, 2020 Synaptive Medical Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1
  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:
Synaptive Medical Inc
Reason for Recall:
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Synaptive ImageDrive Clinical

Product Codes/Lot Numbers:

ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1759-2020

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