🔍 RecallPedia

EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2024 Elucent Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION
  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:
Elucent Medical Inc
Reason for Recall:
There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.

Product Codes/Lot Numbers:

Lot Code: All EnVisio Patient Pad Transition Cushions REF: ENVISIO-CUSHION

Distribution:

Distributed in: US, AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0806-2025