🔍 RecallPedia

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Class I - Dangerous
🏥 Medical Devices Recalled: March 1, 2022 Edwards Lifesciences Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.
  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:
Edwards Lifesciences, LLC
Reason for Recall:
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Product Codes/Lot Numbers:

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10, UDI: 00690103208573; All serial numbers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0835-2022

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