🔍 RecallPedia

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Class I - Dangerous
🏥 Medical Devices Recalled: September 21, 2021 Philips Ultrasound Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Software Versions: 6.0, 7.0, 7.0.3
  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:
Philips Ultrasound Inc
Reason for Recall:
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Product Codes/Lot Numbers:

Software Versions: 6.0, 7.0, 7.0.3

Distribution:

Distributed in: US, MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0123-2022

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